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

Catalog Number SGC0302

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Patient Involvement (2645)

Event Date 07/27/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all relevant information.

Event Description

This is filed to report the tear on the device soft tip.It was reported that this was a mitraclip procedure to treat grade 4 functional mitral regurgitation (mr).During the preparation of the steerable guide catheter (sgc), when the sgc was submerged and the dilator was advanced, the nurses noted a small tear on the sgc about one cm from the soft tip.There was no patient involvement.A new sgc was prepared and the procedure continued without further incident.No additional information regarding this device issue was provided.

Manufacturer Narrative

(b)(4).The returned complaint device was investigated but the reported tear on the steerable guide catheter (sgc) soft tip was not confirmed.Additional information from the customer confirmed that the correct device was returned.The soft tip of the sgc was inspected under a keyence microscope and no damage was observed.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to the event.Review of the complaint history identified no similar incidents reported from this lot.A definitive cause for the reported soft tip tear could not be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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
• MDR Report Key: 7783553
• MDR Text Key: 117155907
• Report Number: 2024168-2018-06257
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• PMA/PMN Number: K161985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 10/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/17/2019
• Device Catalogue Number: SGC0302
• Device Lot Number: 80417U133
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2018
• Date Manufacturer Received: 10/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1