MAUDE Adverse Event Report: GREATBATCH MEDICAL PTFE PEELABLE INTRODUCER KIT, 9FR; INTRODUCER, CATHETER

Model Number	1000558-008
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Bradycardia (1751); Cardiac Arrest (1762); Ventricular Tachycardia (2132)
Date of Event	07/01/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an implant of a crtd during the first venipuncture, the patient becomes bradycardic (fc: 25 lpm) and hypotensive (pai: 40/20), which improves with adrenaline and atropine.The procedure continues, dr.(b)(6) advances a left ventricular lead: model: 0296/367061 and a left atrial lead: model: 7741/658410.The patient develops ventricular tachycardia (vt), which the physician defibrillates 200j.Then the patient becomes in pulseless electrical activity and asystole.The physician then performs basic and advanced maneuvers (resuscitation).The patient remains hospitalized in icu.A second procedure was performed (b)(6) 2016 to implant the device and lv lead, with no further adverse effects reported.

• Brand Name: PTFE PEELABLE INTRODUCER KIT, 9FR
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): GREATBATCH MEDICAL; 2300 berkshire lane; minneapolis MN 55441
• MDR Report Key: 5877790
• Report Number: 2183787-2016-00066
• Device Sequence Number: 13744108
• Product Code: DYB
• UDI-Device Identifier: 00802526527852
• UDI-Public: (01)00802526527852(17)171029(10)W3264285
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K102540
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 07/12/2016

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 Expiration Date: 10/29/2017
• Device Model Number: 1000558-008
• Device Catalogue Number: BSC 7093
• Device Lot Number: W3264385
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2016
• Initial Report FDA Received Date: 08/15/2016
• 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