MAUDE Adverse Event Report: WILLIAM COOK EUROPE LUNDERQUIST EXTRA-STIFF DOUBLE CURVED EXCHANGE SUPPORT WIRE GUIDE

Model Number	G45408
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	Atrial Perforation (2511)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Procode: dqx wire, guide, catheter.
Event or Problem Description
Description of event according to initial reporter: patient was undergoing non-surgical aortic valve replacement (avr) with a 26mm corevalve.Using a retrograde percutaneous approach for a transcatheter aortic valve.A 035/180cm lunderquist extra stiff wire was advanced retrograde across the aortic valve to the left ventricular apex.After the delivery of the balloon aortic valvuloplasty, the lunderquist wire was noted to have a abnormal band approximately 40mm from the distal tip at the segment of the wire that is generally bonded.At this point the physician became concerned given the abnormal appearance of the wire for trauma to the left ventricle.A straight pigtail was delivered and the wire was exchanged for a new one.The initial wire was examined and there was no evidence of disruption of the outer core, it just simple appeared to have bent slightly.In caution, an echo was performed and it was noted for a pericardial effusion, patient was stable during procedure, consult placed to cv surgeon, patient brought to or for subxiphild pericardial window followed by sternotomy, cardiopulmonary bypass, and repair left ventricular perforation.Per or report, there was a 1 cm, laceration near the distal end of the circumflex near the apex.Patient outcome: unknown.

• Brand Name: LUNDERQUIST EXTRA-STIFF DOUBLE CURVED EXCHANGE SUPPORT WIRE GUIDE
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• MDR Report Key: 10647881
• Report Number: 3005580113-2020-00421
• Device Sequence Number: 3903755
• Product Code: DQX
• UDI-Device Identifier: 00827002454088
• UDI-Public: (01)00827002454088(17)240423(10)E3842965
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/08/2020
• Report Date (Section F): 10/06/2020

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: 04/23/2024
• Device Model Number: G45408
• Device Catalogue Number: TSCMG-35-300-LESDC
• Device Lot Number: E3842965
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/14/2020
• Event Location: Hospital
• Date Report to Manufacturer: 10/06/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/08/2020
• 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: Required Intervention
• Patient Weight: 72