MAUDE Adverse Event Report: AV-TEMECULA-CT HT PROTURN; GUIDE WIRE

Catalog Number 1044596

Device Problems Kinked (1339); Difficult To Position (1467); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/18/2016

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 was not returned for analysis.The investigation determined the reported difficulties to be related to the patient anatomical conditions.A review of the lot history record revealed no manufacturing nonconformities.Additionally, a review of the complaint history did not indicate a lot specific quality issue.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

It was reported that the procedure was to treat a lesion in the proximal left circumflex (lcx) artery with moderate tortuosity, moderate calcification and 100% stenosis.A proturn guide wire was advanced to the lesion without resistance; however, while an unspecified device was advanced over the guide wire the tip caught slightly with the lesion and the tip shape became bent/curved in an undesirable shape.The proturn guide wire was removed from the patient anatomy, slight resistance was felt with the lesion and the tip was re-shaped; however, the tip could not be re-shaped properly.Thus, the proturn guide wire was replaced with a non-abbott guide wire.There was no reported adverse patient effect and no reported clinically significant delay in the procedure.No additional information was provided.

• Brand Name: HT PROTURN
• Type of Device: GUIDE WIRE
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 5914797
• MDR Text Key: 54201209
• Report Number: 2024168-2016-05810
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 08717648178375
• UDI-Public: (01)08717648178375(17)171130(10)5121061
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K112957
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 08/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2017
• Device Catalogue Number: 1044596
• Device Lot Number: 5121061
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2015
• 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