MAUDE Adverse Event Report: AV-TEMECULA-CT HI-TORQUE WHISPER MS GUIDE WIRE; GUIDE WIRES

Catalog Number 1005359HJ

Device Problems Difficult to Insert (1316); Peeled/Delaminated (1454); Difficult to Remove (1528); Material Protrusion/Extrusion (2979)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/17/2013

Event Type  malfunction  

Event Description

It was reported that a general comment stated this wire would not insert into the insertion tool.Additionally, it was difficult to exit the insertion tool; as polymer peeling/sheared/scuffed [nothing detaching] was noted after removal.The physician noted this is a j shaped tip but it looks funny like it has an extra bend on the tip.There was no adverse patient effect.No additional information was provided.

Manufacturer Narrative

(b)(4).The device was received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

Manufacturer Narrative

(b)(4).Evaluation summary: the complaint device was returned and the reported peeled polymer and difficult to exit the insertion tool was not confirmed, but the difficult to insert/remove the introducer was confirmed via returned device analysis.The reported irregular j shaped tip was found to be an extra bend close to the tip of the returned guide wire.Based on the analysis of the returned devices, there is no indication of a product deficiency.A review of the lot history record revealed no non-conformances that would have contributed to the reported event.A review of the complaint history of the reported lot did not indicate a manufacturing issue.Based on the information reviewed there does not appear to be any indications of a product quality deficiency.

• Brand Name: HI-TORQUE WHISPER MS GUIDE WIRE
• Type of Device: GUIDE WIRES
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 462
• Manufacturer (Section G): BARCELONETA, PUERTO RICO REG# 3005737652; abbott vascular; 26531 ynez road; temecula CA 92591 462
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 3569013
• MDR Text Key: 4075949
• Report Number: 2024168-2014-00233
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101116
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/18/2013

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: 09/30/2015
• Device Catalogue Number: 1005359HJ
• Device Lot Number: 3102171
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/23/2013
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/22/2014
• Initial Date FDA Received: 01/10/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/29/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1