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

Catalog Number SGC0702

Device Problems Failure to Advance (2524); Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/15/2021

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Event Description

This is filed to report the steerable guide catheter (sgc) soft tip tear.It was reported the mitraclip procedure was performed to treat grade 4 degenerative mitral regurgitation.The vessel was dilated with a 20f dilator.When inserting the steerable guide catheter (sgc) ensemble over the stiff wire into the vessel, resistance was felt after approximately 3-4 cm.The sgc was removed, and the sgc soft tip was noted to be torn.The vessel was dilated again and a new sgc was used without issue.One clip was implanted, reducing mr to <1.There were no adverse patient effects and no clinically significant delay in the procedure.

Manufacturer Narrative

The device was returned and investigated.The returned steerable guide catheter (sgc) did not confirm the reported material split/cut as no cut/split was noted.The reported failure to advance could not be replicated in the testing environment; however, the sgc soft tip was noted to be stretched during returned device analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have resulted in this event.Additionally, a review of the complaint history identified no other complaints reported from this lot.All available information was investigated, and a conclusive cause for the reported failure to advance could not be determined; however, the observed stretched sgc soft tip was an outcome of the reported failure to advance.A conclusive cause for the reported material split/cut could not be determined.There is no indication of a product issue with respect to manufacture, design, or labeling.

• Brand Name: G4 STEERABLE GUIDING CATHETER
• Type of Device: CATHETER, STEERABLE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11780412
• MDR Text Key: 262959833
• Report Number: 2024168-2021-03823
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• PMA/PMN Number: K190167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/18/2021
• Device Catalogue Number: SGC0702
• Device Lot Number: 01118U323
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2021
• Initial Date Manufacturer Received: 04/15/2021
• Initial Date FDA Received: 05/05/2021
• Supplement Dates Manufacturer Received: 06/15/2021
• Supplement Dates FDA Received: 06/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1