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

Catalog Number	1044592
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Codes	Perforation (2001); Cardiac Tamponade (2226)
Date of Event	10/10/2018
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 investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that as the guide wire was advanced interaction with the heavily tortuous anatomy resulted in the reported failure to advance the guide wire to the intended location.The reported patient effect of perforation is listed in the hi-torque guide wires instructions for use as a known patient effect of coronary stenting procedures.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.
Event or Problem Description
It was reported that the procedure was to treat a heavily tortuous lesion in the left anterior descending artery (lad).A ht powerturn flex guide wire was being advanced; however, there was difficulty maneuvering the guide wire as it could not be directed into the lad.The guide wire was removed and the procedure was completed with a sport guide wire, unspecified balloon catheter, and unspecified stent.About two hours post procedure the patient was hypotensive.Fluids were administered and an echocardiogram was performed which showed an effusion due to a perforation caused by the ht powerturn flex guide wire distal to the lad.Pericardiocentesis was performed; however, unsuccessful.Medications were administered to help increase the patient's blood pressure.Pericardiocentesis was performed two more times, but failed.The patient was not stable and was sent to surgery.The patient is doing well after pericardial window surgery.No additional information was provided.

• Brand Name: HT POWERTURN FLEX
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 7976053
• Report Number: 2024168-2018-07975
• Device Sequence Number: 1572087
• Product Code: DQX
• UDI-Device Identifier: 08717648173936
• UDI-Public: 08717648173936
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K112957
• 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): 10/17/2018

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: 06/30/2020
• Device Catalogue Number: 1044592
• Device Lot Number: 8073061
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2018
• Initial Report FDA Received Date: 10/17/2018
• 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; Required Intervention
• Patient Age: 82 YR
• Patient Weight: 69