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

Catalog Number 1013317

Device Problems Peeled/Delaminated (1454); Difficult To Position (1467)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/09/2016

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 is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all relevant information.

Event Description

It was reported that during a procedure of the mildly tortuous, concentric, de novo, diagonal (d1) artery, the versaturn guide wire was positioned and the non-abbott balloon dilatation catheter (bdc) met resistance but crossed the d1 and was successfully used in the procedure.A different non-abbott bdc was used over the versaturn, but could not be advanced beyond the balloon shoulder in the guide catheter.The versaturn was removed and outside the anatomy metal filaments were observed on the device.There was no reported adverse patient effect or a clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: visual and dimensional inspections were performed on the returned device.The coil damage was confirmed.The difficult to position could not be replicated in a testing environment due to the condition of the returned device.The physical resistance could not be replicated in a testing environment as it was based on operational circumstances.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 determined the reported difficulties appear to be related to circumstances of the procedure and there is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.

Event Description

Subsequent to the initial 30-day medical device report, the following information was received: a 2.75x18mm xience xpedition stent was implanted in the left anterior descending (lad) coronary artery lesion without reported issue.Following, a versaturn guide wire was difficult to cross into the diagonal 1 (d1) coronary artery.A non-abbott dilatation catheter advanced the versaturn and met resistance while advancing at the level of the right shoulder.The dilatation catheter was able to cross and dilatation was performed on the d1, unspecified stent.A second non-abbott dilatation catheter advanced over the same d1 versaturn guidewire.Again, resistance was met during advancement at the right shoulder level.The versaturn guidewire was removed from the patients anatomy without reported issue.Once outside the anatomy, the balloon catheter was attempted to advance again over the versaturn guidewire.Again resistance was met at 25 centimeters distal from the tip.Loose metal filaments were also noted, still connected to the core.

• Brand Name: HT VERSATURN GUIDE WIRE
• 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: 6219348
• MDR Text Key: 63954428
• Report Number: 2024168-2017-00015
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K103101
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2018
• Device Catalogue Number: 1013317
• Device Lot Number: 6061561
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2016
• 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
• Treatment: DILATATION CATHETER: EMERGE 1.2X12MM, 2.0X12MM