MAUDE Adverse Event Report: AV-TEMECULA-CT MITRACLIP SYSTEM STEERABLE GUIDE CATHETER

Catalog Number SGC0101

Device Problems Mechanical Problem (1384); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/25/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Evaluation summary: all available information was investigated and the reported inability to curve the steerable guiding catheter (sgc) was confirmed.A review of the lot history record revealed no manufacturing nonconformities.Additionally, a review of the complaint history did not indicate a lot-specific quality issue.The investigation determined that the reported inability to curve the sgc was a result of an observed cable break; however, the investigation was unable to determine a conclusive cause for the sgc cable break.Additionally, the soft tip was noted to be torn.No torn material was noted to be missing.As it was reported that the clip did not get caught on the guide tip, there was no resistance noted during removal of the clip delivery system (cds) from the sgc and the patient anatomy is unlikely to have caused the visible damage, the torn soft tip may be a result of post-procedural handling; however, this cannot be definitively determined.The torn soft tip would not have contributed to the reported issues.Based on the information reviewed, there is no indication of a product quality issue with respect to design, manufacture or labeling of the device.

Event Description

This is filed based on returned device analysis which found that the steerable guiding catheter (sgc) soft tip was torn, which has the potential to cause or contribute to patient injury.It was reported that this was a mitraclip procedure to treat mixed mitral regurgitation (mr) with a grade of 4.The steerable guiding catheter (sgc) was advanced without issue.While in the left atrium, the +/- knob was turned approximately 60 degrees in the + direction, but the tip did not respond.The sgc was removed without issue, and replaced.One clip was implanted, reducing the mr to 1.There were no adverse patient effects and no clinically significant delay in the procedure.Returned device analysis found that the sgc soft tip was torn.Follow up with the account confirmed that there was no resistance noted during removal of the delivery system from the sgc and the clip did not get caught on the sgc tip.No additional information was provided.

• Brand Name: MITRACLIP SYSTEM STEERABLE GUIDE CATHETER
• Type of Device: STEERABLE GUIDE CATHETER
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer (Section G): MENLO PARK, CA REG# 3005070406; abbott vascular; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 5943244
• MDR Text Key: 54755024
• Report Number: 2024168-2016-06021
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 08717648195921
• UDI-Public: (01)08717648195921(17)170430(10)60426U110
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112239
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 09/12/2016

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: 04/30/2017
• Device Catalogue Number: SGC0101
• Device Lot Number: 60426U110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/25/2016
• Initial Date FDA Received: 09/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2016
• 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: MITRACLIP SYSTEM
• Patient Age: 81 YR
• Patient Weight: 70