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

Catalog Number SGC0702

Device Problems Difficult to Insert (1316); Material Split, Cut or Torn (4008)

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

Event Date 06/29/2022

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 for a tear in the soft tip.It was reported on 6/29/2022, a patient presented with grade 3 mixed mitral regurgitation (mr) and vessel tortuosity.There was difficulty introducing the g4 steerable guide catheter (sgc).The sgc could not be properly introduced and the device was met with resistance in the tortuous vein.The sgc was removed to dilate the vessel.A tear was noted in the soft tip of the sgc.There was no adverse patient effect or clinically significant delay.A replacement sgc completed the procedure successfully, reducing mr to grade 1-2.No additional information was provided.

Manufacturer Narrative

The device was returned and investigated.The reported material split, cut or torn (soft tip) was confirmed via returned device analysis.The reported difficult to insert (anatomy) could not be replicated in a testing environment.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no similar incidents reported from this lot.Based on available information and the results of the analysis, the reported difficult to insert (anatomy) was due to challenging anatomy.The confirmed material split, cut or torn (soft tip) appears to be related to the difficult to insert.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: G4 STEERABLE GUIDING CATHETER
• Type of Device: CATHETER, STEERABLE
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442 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: 15048712
• MDR Text Key: 298035285
• Report Number: 2024168-2022-07869
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K190167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/21/2022

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: 01/26/2023
• Device Catalogue Number: SGC0702
• Device Lot Number: 20127R247
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/29/2022
• Initial Date FDA Received: 07/18/2022
• Supplement Dates Manufacturer Received: 09/12/2022
• Supplement Dates FDA Received: 09/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/27/2022
• 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