MAUDE Adverse Event Report: ABBOTT VASCULAR HT BALANCE HEAVYWEIGHT HC; GUIDE WIRE

Catalog Number	1000462H
Medical Device Problem Codes	Peeled/Delaminated (1454); Difficult to Remove (1528); Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.G9: exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.Na.
Event or Problem Description
It was reported that the procedure was performed to treat a de novo lesion in the proximal left anterior descending coronary artery with heavy calcification.On advancement and removal of a hi-torque 014 balance middle weight (bmw) hydro guide wire, resistance was noted with a non-abbott balloon dilatation catheter and the coating of the guide wire was thought to fracture/ wear off [peel].None of the coating was reported to separate from the guide wire and guide wire was removed from the anatomy.A new bmw guide wire was used to successfully complete the procedure with the non-abbott balloon catheter.There were no adverse patient effects and no reported clinically significant delay in the procedure.No additional information was provided.
Event or Problem Description
Subsequent to the initial 30-day medwatch report, the following information was identified: the device was inadvertently described as a hi-torque 014 balance middle weight (bmw) hydro guide wire in the procedure description instead of a hi-torque 014 balance heavy weight (bhw) hydro guide wire.Return device analysis identified that the teflon was scraped and not peeled.Follow-up with the account confirmed that the scraped teflon is what was meant by the coating fracturing/ wearing off.This was noted on removal of the guide wire from the patient anatomy.No additional information was provided.
Additional Manufacturer Narrative
Exemption number e2019001.A visual and dimensional inspection were performed on the returned guide wire.The reported difficulty to advance/position and remove the guide wire through a balloon catheter was unable to be confirmed due to the solder joint corrosion and tip ball separation.The reported peeling was unable to be confirmed as there was no peeling noted; however, scraping damage was noted on the core which is likely what was seen during retraction from the anatomy.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 similar incidents reported from this lot.The investigation was unable to determine a conclusive cause for the reported difficulties.Although a conclusive cause for the reported difficulty to advance/position, difficult to remove and peeling could not be identified, the corrosion noted on the tip solder was likely a result of exposure to the elements during transit back to abbott vascular for analysis.The reported/noted teflon damage was likely caused by the torque device used in the procedure.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: HT BALANCE HEAVYWEIGHT HC
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 8876221
• Report Number: 2024168-2019-10690
• Device Sequence Number: 11360428
• Product Code: DQX
• UDI-Device Identifier: 08717648015489
• UDI-Public: 08717648015489
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K021228
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2021
• Device Catalogue Number: 1000462H
• Device Lot Number: 9022171
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2019
• Initial Date Received by Manufacturer: 07/18/2019
• Supplement Date Received by Manufacturer: 10/15/2019
• Initial Report FDA Received Date: 08/08/2019
• Supplement Report FDA Received Date: 10/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BALLOON CATHETER MEDTRONIC SPRINTER
• Outcome Attributed to Adverse Event: Required Intervention