MAUDE Adverse Event Report: ABBOTT VASCULAR HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE WIRE

Model Number	1009660J
Medical Device Problem Codes	Difficult to Remove (1528); Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that a balance middleweight (bmw) universal guide wire was advanced through the guide catheter and got stuck, during removal resistance was met with the guiding catheter, the physician maneuvered the guide wire and it was successfully removed.Another attempt to advance the guide wire was made; however, it met resistance with the guide catheter again.The guide wire was removed and another bmw guidewire was used to successfully complete the procedure.There was no adverse patient effects and no clinically significant delay.No additional information was provided.
Additional Manufacturer Narrative
The device was returned for analysis.The reported difficulties were not confirmed.There is noted damage to the shaping ribbon and coils likely caused by handling during the procedure.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 similar incidents from this lot.The investigation was unable to determine a conclusive cause for the reported difficulties.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.D10, h3 - device available for eval updated from "no" to "yes".H6: method code 4115 removed.
Additional Manufacturer Narrative
The device was not returned for evaluation.However, factors that can contribute to difficult to position and difficult to remove include, but are not limited to, preparation technique, damaged devices, device interactions or anatomical conditions.The product risk assessment identifies this as a foreseeable event; as such, design and manufacturing controls and mitigation's have been established for potential causes.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 similar incidents from this lot.The investigation was unable to determine a conclusive cause for the reported difficulties.It possible that the guidewire experienced problems with the associated device (6fr guide catheter) causing the reported difficulties to remove and advance; however, without the device to examine this cannot be confirmed.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.D10: h3: return status updated from yes to no.
Event or Problem Description
Subsequent to the initial filed report additional information was received: the bmw universal guide wire was advanced through a 6fr guide catheter.

• Brand Name: HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE WIRE
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10345268
• Report Number: 2024168-2020-06328
• Device Sequence Number: 3399199
• Product Code: DQX
• UDI-Device Identifier: 08717648065866
• UDI-Public: 08717648065866
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K101011
• 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,Followup
• Report Date (Section B): 12/29/2020

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: 12/31/2021
• Device Model Number: 1009660J
• Device Catalogue Number: 1009660J
• Device Lot Number: 0012471
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2020
• Initial Date Received by Manufacturer: 07/13/2020
• Supplement Date Received by Manufacturer: 09/09/2020; 12/23/2020
• Initial Report FDA Received Date: 07/30/2020
• Supplement Report FDA Received Date: 09/10/2020; 12/29/2020
• 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: GUIDE CATHETER: 6FR