MAUDE Adverse Event Report: ABBOTT VASCULAR G4 STEERABLE GUIDING CATHETER; CATHETER, STEERABLE

Catalog Number SGC0705

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Atrial Perforation (2511)

Event Date 01/21/2021

Event Type  Injury  

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event.The reported patient effect of atrial perforation as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures.Based on the available information, a cause for the reported atrial perforation could not be determined.The reported additional therapy/non-surgical treatment was a result of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design or labeling.The thrombosis referenced is filed under another mfr report number.

Event Description

This is filed to report the atrial perforation.It was reported that this was a mitraclip procedure performed to treat functional mitral regurgitation (mr) with an mr grade of 4.One clip was implanted without issues and mr was reduced to 1.After clip implantation, the reduction of mr may have resulted in thrombosis.After removal of the steerable guide catheter, a right to left shunt occurred, requiring a closure device for treatment.No additional information was provided.

• Brand Name: G4 STEERABLE GUIDING CATHETER
• Type of Device: CATHETER, STEERABLE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 11276849
• MDR Text Key: 230227094
• Report Number: 2024168-2021-00861
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K190167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/16/2021
• Device Catalogue Number: SGC0705
• Device Lot Number: 01017U159
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/17/2020
• 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
• Treatment: IMPLANTED MITRACLIP(X1)
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Weight: 65