MAUDE Adverse Event Report: AV-TEMECULA-CT HT POWERTURN FLEX; GUIDE WIRE

Catalog Number	1044592
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	01/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device was not returned for evaluation.The reported patient effect of perforation is listed in the hi-torque guide wires for ptca, pta, and stents instructions for use as a known patient effect of coronary stenting procedures.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.A conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined; however, the treatment appears to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that the procedure was performed to treat a 50% stenosed and heavily tortuous lesion in the mid right coronary artery (rca).A ht powerturn flex guide wire was being advanced through the distal rca which had a very sharp tortuous curve (approximately 150-degree bend).During the insertion and transition of this curve, it appears that the powerturn flex guide wire perforated the distal rca.This was seen by contrast injection and mild contrast staining in the distal rca area.A 2.0 x 30mm trek balloon dilatation catheter was used to balloon the perforation for 5 minutes and then two additional 15 minute intervals to help with clotting the perforated area.A mobile echo/ultrasound check was performed in between each inflation interval for pericardial effusion and none was noted.When all appeared to be stable, the procedure was aborted.The patient was sent to the intensive care unit for monitoring and is in stable condition.The patient will not receive any more coronary interventions.No additional information was provided.

• Brand Name: HT POWERTURN FLEX
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 8242431
• Report Number: 2024168-2019-00313
• Device Sequence Number: 1929137
• Product Code: DQX
• UDI-Device Identifier: 08717648173936
• UDI-Public: 08717648173936
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K112957
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 01/11/2019

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: 07/31/2020
• Device Catalogue Number: 1044592
• Device Lot Number: 8080261
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2019
• Initial Report FDA Received Date: 01/11/2019
• 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: 85 YR