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

Catalog Number	1005359H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Intimal Dissection (1333); Thrombosis (2100)
Date of Event	08/20/2018
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.The device was not returned for analysis.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 reported patient effect of dissection is listed in the hi-torque guide wires instructions for use as a known patient effect of coronary stenting procedures.The investigation determined a conclusive cause for the reported detachment cannot be determined.The reported detachment possibly contributed to the reported dissection and thrombosis; however a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.(b)(4).(b)(4).
Event or Problem Description
It was reported the patient admitted with chest pain on (b)(6) 2018.Patient was taken for cardiac catheterization on (b)(6) 2018 and was found to have multivessel coronary artery disease.The patient was deemed not to be a good candidate for bypass surgery; percutaneous transluminal coronary angioplasty (ptca) with stenting to the left anterior descending (lad) was done on (b)(6) 2018 and returned to the cath lab on (b)(6) 2018 for intervention in the obtuse marginal (om) and circumflex (cx) branches.During the procedure while the physician was attempting to advance a stent to the om branch, the whisper wire fractured and broke off in the cx marginal branch.The physician attempted to retrieve the fractured wire during which the patient developed thrombosis of the left circumflex with dissection.Patient was transferred to memorial regional hospital for evaluation by cardiothoracic surgery to determine if further attempts at retrieval of the wire fragment would be done or cardiac surgery.Open heart surgery was performed to remove the separated portion of the guide wire.No additional information was provided.

• Brand Name: HI-TORQUE WHISPER MS 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: 7839489
• Report Number: 2024168-2018-06834
• Device Sequence Number: 11214769
• Product Code: DQX
• UDI-Device Identifier: 08717648037825
• UDI-Public: 08717648037825
• 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: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 08/31/2018

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: 1005359H
• Device Lot Number: 7082271
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2018
• Initial Report FDA Received Date: 08/31/2018
• 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: Hospitalization; Other; Required Intervention
• Patient Age: 72 YR
• Patient Weight: 68