MAUDE Adverse Event Report: COOK VASCULAR INC LEAD EXTRACTION NEEDLE'S EYE FEMORAL SNARE AND WORKSTATION; 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 Codes	Cardiopulmonary Arrest (1765); Cardiac Perforation (2513)
Date of Event	04/14/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
During a procedure to remove the electrode, the heart got punctured.The former capped rv lead, originally implanted in 2005, was grabbed with the cook lead extractor.The lead could also be grabbed with a lead extraction needle's eye femoral snare and the outer sheath was pushed forward until there was a 2 cm distance to the tip.The lead was extracted successfully.After a moment, the patient's blood pressure dropped and open heart surgery was performed.The patient had to be reanimated (resuscitated) during the procedure.A small hole in the right ventricle was found.The patient felt well when she left the or.A section of the device did not remain inside the patient's body.The patient did require external and internal defibrillation.According to the initial reporter, the patient did not experience any adverse effects after to this occurrence.
Additional Manufacturer Narrative
Product code: dre.(b)(4).Investigation/evaluation: a review of complaint history and device history record along with a visual inspection and functional test of the returned device was conducted during the investigation.One used device was received with this complaint.During the evaluation, the device was inspected under magnification, and no damage, anomalies, or nonconformities that could have caused the bleeding were observed.A functional test was performed and the device functioned as intended.There are no signs that this device contained an attribute that contributed to this complaint.Based on the investigation provided and the investigation of the returned device, it is unknown if the device contacted the heart wall or if the hole was caused by the removal of the lead.No information was provided to indicate the device malfunctioned, contained a nonconformity, or was misused.We will continue to monitor for similar complaints.Per the quality engineering risk assessment (qera) no further action is required.
Event or Problem Description
During a procedure to remove the electrode, the heart got punctured.The former capped rv lead, originally implanted in 2005, was grabbed with the cook lead extractor.The lead could also be grabbed with a lead extraction needle's eye femoral snare and the outer sheath was pushed forward until there was a 2 cm distance to the tip.The lead was extracted successfully.After a moment, the patient's blood pressure dropped and open heart surgery was performed.The patient had to be reanimated (resuscitated) during the procedure.A small hole in the right ventricle was found.The patient felt well when she left the or.A section of the device did not remain inside the patient's body.The patient did require external and internal defibrillation.According to the initial reporter, the patient did not experience any adverse effects after to this occurrence.

• Brand Name: LEAD EXTRACTION NEEDLE'S EYE FEMORAL SNARE AND WORKSTATION
• Common Device Name: DRE DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• Manufacturer (Section D): COOK VASCULAR INC; 1186 montgomery lane; vandergrift PA 15690
• MDR Report Key: 5637584
• Report Number: 1820334-2016-00298
• Device Sequence Number: 10808363
• Product Code: DRE
• UDI-Device Identifier: 00827002265172
• UDI-Public: (01)00827002265172(17)180930(10)N131924
• Combination Product (Y/N): N
• 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): 04/14/2016

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?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/14/2016
• Device Age: 6 MO
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/19/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/06/2016
• Supplement Report FDA Received Date: 06/14/2016
• 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: Other