MAUDE Adverse Event Report: AV-TEMECULA-CT HI-TORQUE COMMAND 18 GUIDE WIRE

Catalog Number 1013731

Device Problems Break (1069); Difficult to Insert (1316); Stretched (1601)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/17/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.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.

Event Description

It was reported the procedure was to treat a moderately tortuous lesion in the right anterior tibial artery.A high-torque command 18 guide wire was advanced to the lesion through an abbott guide wire introducer.Following, a non-abbott balloon dilatation catheter (bdc) being advanced over the guide wire to successfully dilate the lesion, the guide wire and bdc were removed with no reported issue.The guide wire was then attempted to be re-advanced; however, when inserting the guide wire into the introducer needle, the tip of the guide wire was noted to have unraveled and could not be inserted into the introducer.The guide wire was therefore not re-advanced and a new unspecified guide wire used to complete the procedure without the use of the guide wire introducer.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.

Manufacturer Narrative

Internal file number (b)(4).Evaluation summary: visual and dimensional inspections were performed on the returned guide wire.The reported core break and stretched coils were unable to be confirmed.The reported difficulty to insert the wire though a guide wire introducer was unable to be confirmed due to the noted polymer damages.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 from this lot.The investigation was determined the reported/noted difficulties appears to be related to circumstances of the procedure.Based on the reported information and returned analysis, it is likely that the guide wire was pulled out of the guide wire introducer at an angle causing in the polymer damages resulting in the difficulty to reinsert into the guide wire introducer and the appearance of stretched coils and a broken core.The polymer separations were noted to be folded over itself distally and is consistent with the guide wire being pulled out proximally through the guide wire introducer.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: HI-TORQUE COMMAND 18 GUIDE WIRE
• Type of Device: GUIDE WIRE
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 8593059
• MDR Text Key: 144556599
• Report Number: 2024168-2019-03671
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• PMA/PMN Number: K152404
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 06/03/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Catalogue Number: 1013731
• Device Lot Number: 8081361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2019
• Initial Date Manufacturer Received: 04/18/2019
• Initial Date FDA Received: 05/08/2019
• Supplement Dates Manufacturer Received: 05/24/2019
• Supplement Dates FDA Received: 06/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GUIDE WIRE INTRODUCER
• Patient Age: 81 YR
• Patient Weight: 79