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

Catalog Number	1044593
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Vessel Or Plaque, Device Embedded In (1204)
Date of Event	01/24/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Concomitant medical product: guide wire: mailman.The device was returned for analysis.The reported detachment was able to be confirmed.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents from this lot.As there was no damage noted to the guide wire during the inspection prior to use, the investigation determined the reported difficulties appear to be related to circumstances 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 to treat a heavily tortuous and heavily calcified obtuse marginal branch during a jump graft procedure.A 300 cm powerturn flex guide wire was advanced towards the lesion and did not meet any resistance during advancement or removal.Approximately five unspecified stents were implanted in the lesion, and unspecified balloon catheters were used.However, during the fourth or fifth stent deployment, it was noted under fluoroscopy that the unspecified stent delivery system (sds) was in the left anterior descending artery instead of the target lesion.Therefore, both the sds and guide wire were pulled back; however, the tip of the guide wire separated in the obtuse marginal branch.There were multiple failed attempts to snare the tip and balloon inflation was also performed.A non-abbott guide wire was then used along with the powerturn guide wire.A 2.75 x 8 mm unspecified xience stent was advanced over the non-abbott guide wire and deployed to embed the tip of the powerturn guide wire in the obtuse marginal branch.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: 8347521
• Report Number: 2024168-2019-01177
• Device Sequence Number: 1832762
• Product Code: DQX
• UDI-Device Identifier: 08717648173950
• UDI-Public: 08717648173950
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 02/18/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: 1044593
• Device Lot Number: 8071161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2019
• Initial Report FDA Received Date: 02/18/2019
• 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: 72 YR
• Patient Weight: 111