CLOVERSNARE¿ 4-LOOP VASCULAR RETRIEVER

Additional Manufacturer Narrative

BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR UNCHANGED. ADDITIONAL INFORMATION: B5 THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

Description of Event or Problem

ADDITIONAL INFORMATION WAS RECEIVED 07JUN2023. THE FILTER BEING RETRIEVED WAS A COOK CELECT PLATINUM FILTER, WHICH HAD BEEN IN PLACE FOR THREE-TO-SIX MONTHS. THE SNARE SUCCESSFULLY CAPTURED THE FILTER HOOK. THE SNARE DID NOT MALFUNCTION.

Additional Manufacturer Narrative

B1, H1, H6 (ANNEX A): UPON FURTHER REVIEW, THIS COMPLAINT IS NOT REPORTABLE UNDER FDA 21 CFR PART 803. ALTHOUGH THE SNARE WAS DIFFICULT TO ATTACH TO THE FILTER HOOK, THE HOOK WAS CAPTURED WITH THE SNARE AND THE FILTER WAS SUCCESSFULLY REMOVED. PER THE USER, THE SNARE DID NOT MALFUNCTION. PER A SEARCH OF RISK DOCUMENTATION AND PREVIOUS COMPLAINT DATA, THERE IS NO EVIDENCE TO SUGGEST THAT DIFFICULTY CAPTURING A FILTER HOOK WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR A SERIOUS INJURY IF A SIMILAR EVENT WERE TO RECUR. FURTHERMORE, THERE IS NO EVIDENCE THAT THE DEVICE CAUSED OR CONTRIBUTED TO A SERIOUS INJURY, AS NO LIFE-THREATENING OR PERMANENTLY IMPAIRING INJURY WAS ALLEGED, NOR WAS INTERVENTION TAKEN AS A RESULT OF THE DEVICE FAILURE WHICH WOULD BE REQUIRED TO PREVENT PERMANENT IMPAIRMENT OR DAMAGE TO THE PATIENT. AS SUCH, THE EVENT IS NOT REPORTABLE UNDER FDA 21 CFR PART 803 AS IT DOES NOT MEET THE CRITERIA FOR A DEATH, SERIOUS INJURY, OR REPORTABLE PRODUCT MALFUNCTION. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

Description of Event or Problem

NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

Description of Event or Problem

AS REPORTED, A CLOVERSNARE 4-LOOP VASCULAR RETRIEVER WAS USED DURING A PROCEDURE INVOLVING RETRIEVAL OF AN UNKNOWN INFERIOR VENA CAVA FILTER. THE PHYSICIAN REPORTED THAT THE "THROW OF THE SNARE" WAS TOO SHORT AND THEREFORE LIMITED "DIRECTIONALITY" IN THE CASE. THE INNER "DILATOR" WAS REMOVED FROM THE SHEATH IN ORDER TO RETRIEVE THE FILTER. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

Additional Manufacturer Narrative

CUSTOMER PHONE: (B)(6). THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.