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

Catalog Number	1001780S
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/07/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).Medwatch voluntary report (report number not provided) evaluation summary: the device was returned for analysis.The reported detachment was able to be confirmed.The reported entrapment unable to be replicated in a testing environment as it was based on operational circumstances.Reportedly, the procedure was to implant an unspecified biventricular implantable cardioverter defibrillator.It should be noted the instructions for use (ifu) states: all hi-torque guide wires are intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (ptca) and percutaneous transluminal angioplasty (pta).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.The investigation determined the reported/noted difficulties appear to be related to circumstances of the procedure and subsequent use error as it is likely that during withdrawal, the ht bmw guide wire became entangled with the screw of the unspecified screw-in left ventricular lead resulting in the reported entrapment.Manipulation of the guide wire resulted in the noted damages (bent core, stretched coils) and ultimately resulted in the reported/noted detachments (core, coil).There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that the procedure was to implant an unspecified biventricular implantable cardioverter defibrillator (bi-v icd) in the moderately tortuous, non-calcified, mid coronary sinus branch.A hi-torque (ht) balance middleweight (bmw) guide wire was selected for the procedure.During withdrawal from the anatomy, the ht bmw guide wire became entangled with screw of the unspecified screw-in left ventricular (lv) lead and the distal tip of the guide wire broke off.It was determined that the broken tip was tangled to a point that leaving it alone was the safest way to ensure it did not dislodge and embolize elsewhere.No additional information provided.

• Brand Name: ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE
• Common Device Name: GUIDE WIRES
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 7266783
• Report Number: 2024168-2018-01043
• Device Sequence Number: 1917756
• Product Code: DQX
• UDI-Device Identifier: 08717648013836
• UDI-Public: 08717648013836
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K101116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 02/13/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2019
• Device Catalogue Number: 1001780S
• Device Lot Number: 7081871
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2018
• Initial Report FDA Received Date: 02/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 75 YR