FILIFORM DOUBLE PIGTAIL URETERAL STENT SET

Additional Manufacturer Narrative

BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. E1 - PHONE NUMBER: (B)(6) G4 ¿ PMA/510(K) #: PREAMENDMENT INVESTIGATION ¿ EVALUATION AS REPORTED, DURING A TRANSURETHRAL URETERAL STENT PLACEMENT FOR IDIOPATHIC HYDRONEPHROSIS, THE STENT OF THE FILIFORM DOUBLE PIGTAIL URETERAL STENT SET BECAME ENTANGLED WITH THE GUIDEWIRE, PREVENTING ITS REMOVAL AFTER PLACEMENT. ULTIMATELY, BOTH THE STENT AND GUIDEWIRE WERE WITHDRAWN TOGETHER. WHILE SEPARATING THE STENT FROM THE GUIDEWIRE, SOME STENT FRAGMENTS DETACHED. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THE DEVICE FAILURE ANALYSIS OF THE RETURNED DEVICE APPEARED TO SHOW THE STENT BROKEN. REVIEWS OF DOCUMENTATION INCLUDING THE COMPLAINT HISTORY, DEVICE HISTORY RECORD (DHR), QUALITY CONTROL PROCEDURES, MANUFACTURING INSTRUCTIONS (MI), AND INSTRUCTIONS FOR USE (IFU), AS WELL AS A VISUAL INSPECTION OF THE RETURNED DEVICE, WERE CONDUCTED DURING THE INVESTIGATION. A DEVICE FAILURE ANALYSIS WAS CONDUCTED AT COOK AS THE DEVICE WAS RETURNED. THE DEVICE WAS RETURNED IN OPEN PACKAGING WITH THE LABEL. THE WIRE GUIDE WAS NOT RETURNED. THE STENT WAS NOTED TO BE BROKEN CONFIRMING THE CUSTOMER COMPLAINT. ADDITIONALLY, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE MASTER RECORD (DMR) CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. A REVIEW OF THE DEVICE HISTORY RECORD SHOWED NO DISCREPANCIES RELATED TO THE REPORTED FAILURE MODE. A REVIEW OF COMPLAINT HISTORY RECORDS SHOWED NO COMPLAINTS ASSOCIATED WITH THE COMPLAINT DEVICE LOT. BASED ON THE AVAILABLE INFORMATION, COOK HAS CONCLUDED THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION AND THAT THERE IS NO EVIDENCE SUGGESTING NONCONFORMING PRODUCT EXISTS EITHER IN HOUSE OR IN THE FIELD. COOK ALSO REVIEWED PRODUCT LABELING. THE PRODUCT IFU, [T_DPSS_REV3] ¿FILIFORM DOUBLE PIGTAIL URETERAL STENT¿ CONTAINS THE FOLLOWING INFORMATION RELATED TO THE REPORTED FAILURE MODE. ¿PRECAUTIONS ¿ DO NOT FORCE SET COMPONENTS DURING PLACEMENT, REPLACEMENT, OR REMOVAL. CAREFULLY REMOVE THE SET COMPONENTS IF ANY RESISTANCE IS ENCOUNTERED.¿ ¿HOW SUPPLIED ¿ UPON REMOVAL FROM PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED.¿ BASED ON THE INFORMATION PROVIDED, INSPECTION OF THE RETURNED DEVICE, AND THE RESULTS OF THE INVESTIGATION, THE CAUSE OF THE BREAK WAS NOT ABLE TO BE DETERMINED FOR THIS INCIDENT. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. 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

AS REPORTED, DURING A TRANSURETHRAL URETERAL STENT PLACEMENT FOR IDIOPATHIC HYDRONEPHROSIS, THE STENT OF THE FILIFORM DOUBLE PIGTAIL URETERAL STENT SET BECAME ENTANGLED WITH THE GUIDEWIRE, PREVENTING ITS REMOVAL AFTER PLACEMENT. ULTIMATELY, BOTH THE STENT AND GUIDEWIRE WERE WITHDRAWN TOGETHER. WHILE SEPARATING THE STENT FROM THE GUIDEWIRE, SOME STENT FRAGMENTS DETACHED. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.