MAUDE Adverse Event Report: AV-TEMECULA-CT ACS HI-TORQUE IRON MAN GUIDE WIRE

Catalog Number 1001311S

Device Problem Peeled/Delaminated (1454)

Patient Problems No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)

Event Date 11/28/2018

Event Type  Injury  

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 that the procedure was to treat an eccentric de novo lesion located in the proximal left anterior descending coronary artery that was non-tortuous, mildly calcified and 75% stenosed.The hi-torque ironman guide wire was being used for directional coronary atherectomy.Upon removal of the guide wire, it was noted that the coating was peeled (but not separated) when the product was visually inspected.According to the operating physician, no peeled coating was left in the patient.There were adverse patient effects or clinically significant delay in the procedure.No resistance was met during advancement or removal of the guide wire.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned for analysis.The reported peeled teflon was able to be confirmed.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.The noted hook shaped bend likely resulted from shaping of the tip.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

Subsequent to the previously filed medwatch report, the following additional information was received: the physician said he did not scan the patient to see if any peeled teflon could be seen.No additional information was provided.

• Brand Name: ACS HI-TORQUE IRON MAN 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: 8177165
• MDR Text Key: 131185901
• Report Number: 2024168-2018-09847
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K060449
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2019
• Device Catalogue Number: 1001311S
• Device Lot Number: 7091561
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/28/2018
• Initial Date FDA Received: 12/18/2018
• Supplement Dates Manufacturer Received: 01/04/2019
• Supplement Dates FDA Received: 01/15/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2017
• 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
• Patient Outcome(s): Other