MAUDE Adverse Event Report: AV-TEMECULA-CT ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE; GUIDE WIRES

Catalog Number 1001780JS

Device Problems Break (1069); Difficult to Insert (1316); Peeled/Delaminated (1454); Material Separation (1562); Material Twisted/Bent (2981)

Patient Problem No Patient Involvement (2645)

Event Date 11/30/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The customer reported the device was discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that during preparation on the table prior to the procedure, a (b)(6)balance middle weight (bmw) hydro guide wire was being inserted into an abbott guide wire introducer.The tip of the guide wire peeled and twisted and the coils separated.There was no patient involvement.The procedure was completed with a new bmw guide wire.There was no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Device codes: 1562 labeled.(b)(4).Correction: device code 1069 was removed.The device was not returned for analysis.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 as it is likely that as the guide wire was being inserted into the abbott guide wire introducer, the guide wire hydrophilic coating was not properly activated and/or interaction with the guide wire introducer resulted in the reported difficult to insert.Manipulation of the device resulted in the reported peeling, the reported material twisted and ultimately resulted in the reported detachment.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

Subsequent to the initially filed report, the following information was received: resistance was met on inserting the 014 balance middle weight (bmw) hydro guide wire into the abbott guide wire introducer.The coils twisted and separated and the guide wire was confirmed to be in two pieces.The procedure was completed with a new bmw guide wire and the same guide wire introducer.No additional information was provided.

• Brand Name: ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE
• Type of Device: GUIDE WIRES
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 8176064
• MDR Text Key: 131184679
• Report Number: 2024168-2018-09821
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• PMA/PMN Number: K101116
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/07/2019

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: 1001780JS
• Device Lot Number: 8083171
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/30/2018
• Initial Date FDA Received: 12/18/2018
• Supplement Dates Manufacturer Received: 01/02/2019
• Supplement Dates FDA Received: 01/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GUIDE WIRE INTRODUCER: ABBOTT VASCULAR