MAUDE Adverse Event Report: COOK VASCULAR INC LEAD EXTRACTION NEEDLE'S EYE FEMORAL SNARE AND WORKSTATION; DXE CATHETER, EMBOLECTOMY

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	07/01/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Event is still under investigation at this time.
Event or Problem Description
Active fixation right atrial lead that had been previously been attempted to be extracted, was extracted successfully with cook femoral kit.(lead extraction, previous attempt with laser in (b)(6) 2016 in (b)(6)).Left sided rv lead was also successfully extracted with cook femoral kit.Right sided rv lead, attempted extraction with cook femoral kit, partial extraction completed.(distal tip of lead plus 3-4cm of inner core wire left in situ in rv).Upon stopping the procedure to finish, the patients bp (blood pressure) dropped.Cpr was performed and the surgeon performed femoral by-pass and thoracotomy.Tamponade from right atrial appendage and oozing from innominate vein.It should be noted that it was not suggested that this was caused by any cook product, rather that the active fix atrial lead that had been cut previously was the cause.The patient ultimately passed away (died) (b)(6) from ischaemic bowel.Additional information was provided 28july; which stated: no products from cook medical were at fault or failed to function correctly.The active fixation right atrial lead had been cut earlier this year when an attempted laser extraction was performed.The tamponade was caused by this and not the current method of extraction.There was not a device failure, but a complication due to the lead extraction that caused the adverse event.
Additional Manufacturer Narrative
(b)(4).Investigation - evaluation.A review of complaint history and device record history was conducted during the investigation.The device is shipped with an instruction for use (ifu) that describes the intended use and the lead extraction process are covered and warned against.The complaint device was not returned therefore, no physical examinations could be performed; however, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.Review of device history record shows no nonconforming events which could contribute to this failure mode.It should be noted that there are no other complaints of any nature associated with this lot.Based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be determined.Per the quality engineering risk assessment no further action is required.
Event or Problem Description
Active fixation right atrial lead that had been previously been attempted to be extracted, was extracted successfully with cook femoral kit.(lead extraction, previous attempt with laser in (b)(6) 2016 in (b)(6)).Left sided rv lead was also successfully extracted with cook femoral kit.Right sided rv lead, attempted extraction with cook femoral kit, partial extraction completed.(distal tip of lead plus 3-4cm of inner core wire left in situ in rv) upon stopping the procedure to finish, the patients bp (blood pressure) dropped.Cpr was performed and the surgeon performed femoral by-pass and thoracotomy.Tamponade from right atrial appendage and oozing from innominate vein.It should be noted that it was not suggested that this was caused by any cook product, rather that the active fix atrial lead that had been cut previously was the cause.The patient ultimately passed away (died) monday (b)(6) from ischaemic bowel.Additional information was provided 28july; which stated: no products from cook medical were at fault or failed to function correctly.The active fixation right atrial lead had been cut earlier this year when an attempted laser extraction was performed.The tamponade was caused by this and not the current method of extraction.There was not a device failure, but a complication due to the lead extraction that caused the adverse event.

• Brand Name: LEAD EXTRACTION NEEDLE'S EYE FEMORAL SNARE AND WORKSTATION
• Common Device Name: DXE CATHETER, EMBOLECTOMY
• Manufacturer (Section D): COOK VASCULAR INC; 1186 montgomery lane; vandergrift PA 15690
• MDR Report Key: 5830506
• Report Number: 1820334-2016-00722
• Device Sequence Number: 10829830
• Product Code: DXE
• UDI-Device Identifier: 00827002265172
• UDI-Public: (01)00827002265172(17)190228(10)N135407
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K961992
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: LR-NES001
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/01/2016
• Device Age: 3 YR
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 07/01/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/28/2016
• Supplement Report FDA Received Date: 09/13/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 DA