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

Model Number SGC0701

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

Patient Problems Anemia (1706); Hemorrhage/Bleeding (1888)

Event Date 05/01/2020

Event Type  Injury  

Manufacturer Narrative

The device was discarded and will not return for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event.In this case, there was no reported device malfunction associated with the steerable sleeve guiding catheter (sgc).The reported patient effect of bleeding (hemorrhage) is listed in the instructions for use as a known possible complication associated with mitraclip procedures.Based on the information reviewed, the reported patient effect of hemorrhage was likely a result of post-procedural conditions as the sgc was inserted into the anatomy through an incision during the mitraclip procedure; the reported anemia (drop in hemoglobin) was likely a secondary effect of the hemorrhage.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

This report is filed against the steerable guide catheter due to access site bleeding, patient id: (b)(6).It was reported that on (b)(6) 2020, the patient presented with chronic, ischemic functional mitral regurgitation (mr) grade 4+, and primary jet located a2p2.One mitraclip was implanted at the a2p2 without a device deficiency.The mr had been reduced to grade 1+.On (b)(6) 2020, low hemoglobin of 8.5 g/dl was noted and on (b)(6) 2020, oozing at the femoral access site was observed.Anti-platelet medication was held and one unit of red blood cells was provided.The event required prolonged hospitalization.On (b)(6) 2020, the event resolved without sequela.Per physician, there was no device issue.No additional information was provided regarding this issue.

• 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: 10089487
• MDR Text Key: 192146012
• Report Number: 2024168-2020-04504
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 08717648231025
• UDI-Public: 08717648231025
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/02/2020
• Device Model Number: SGC0701
• Device Catalogue Number: SGC0701
• Device Lot Number: 00103U113
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/05/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/03/2020
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 73 YR
• Patient Weight: 72