MAUDE Adverse Event Report: COOK VASCULAR INC LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET; DRE DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	01/31/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
It was reported by the user facility that a patient underwent a lead extraction procedure using a lead extraction evolution rl controlled-rotation dilator sheath set.The attending physician indicated that the locking stylet and one tie was place in the patient while attempting to extract with the lr-evn-13.0-rl.Once traction was applied to the lead and locking stylet, the lead pulled away from the right ventricle and perforated the ventricle.The lr-evn-13.0-rl was not anywhere near the tip of the lead.The lead screw that was at the tip of the lead did not retract, therefore it was still scared in and adhered to the heart wall; when traction was applied, perforation occurred.An open chest procedure was performed to repair the perforation.Patient is in stable condition.The physician feels this incident was not product related.There were no unintended sections of the device that remained inside of the patient¿s body, nor did the patient experience any adverse effects due to this occurrence.No further information was provided.
Additional Manufacturer Narrative
Corrected information: report source: user facility, company representative.Investigation summary: a review of the complaint history, documentation, device history record, instructions for use(ifu), quality control, and manufacturing instructions were conducted during the investigation.The complaint device was not returned therefore, device failure analysis and physical examination of the device used in this case could not be performed.The ifu was reviewed and a warning and list of potential adverse event are included is, one potential adverse event is: laceration or tearing of vascular structures or the myocardium, among other adverse events that are listed.One of the warnings that is listed : "when using dilator sheaths or sheath sets do not insert more than one sheath set into a vein at a time.Severe vessel damage, including venous wall laceration requiring surgical repair, may occur." additionally, a document based investigation evaluation was performed.There was no evidence to suggest the product was not made to specifications.A review of the device history record found no other non-conformances associated with the complaint device lot number.There was no evidence to suggest all items in the lot or similar devices in house are nonconforming/defective.Based on the information provided 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.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.

• Brand Name: LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET
• Common Device Name: DRE DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• Manufacturer (Section D): COOK VASCULAR INC; 1186 montgomery lane; vandergrift PA 15690
• MDR Report Key: 6371401
• Report Number: 2522007-2017-00007
• Device Sequence Number: 16254105
• Product Code: DRE
• UDI-Device Identifier: 10827002237473
• UDI-Public: (01)10827002237473(17)190930(10)N141302
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: LR-EVN-13.0-RL
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/31/2017
• Supplement Date Received by Manufacturer: 11/15/2017
• Initial Report FDA Received Date: 03/02/2017
• Supplement Report FDA Received Date: 12/15/2017
• 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: Life Threatening
• Patient Age: 68 DA