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

Catalog Number SGC01ST

Device Problems Peeled/Delaminated (1454); Physical Property Issue (3008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/03/2015

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 investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Event Description

This report is being filed because the device coating was peeling, which has the potential to cause or contribute to serious injury if a portion is left behind in the patient.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4.After loading of the steerable guide catheter (sgc) onto the guide wire, but prior to entering the patient, a rough spot was noted on the sgc shaft and the coating of the sgc was removable by minor smooth scratching with finger.The sgc was not used.There were no reported adverse patient effects and no reported clinically significant delay in the procedure.A new sgc was used to successfully complete the procedure with mr reduced to grade 1.There was no additional information provided.

Manufacturer Narrative

(b)(4).Evaluation summary: the complaint device was returned for evaluation and the reported irregular appearance on the distal shaft and peeling were confirmed via returned device analysis.However, after review of the irregularity it was determined that that the small irregularity in the hydrophilic coating identified during device analysis met inspection acceptance criteria; therefore, there is no issue regarding this observation.In addition, the reported peeling was likely a result of user technique and handling, as the coating was scratched off.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history identified no similar incidents reported from this lot.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.

Manufacturer Narrative

(b)(4).

• 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: 5242550
• MDR Text Key: 32092310
• Report Number: 2024168-2015-07076
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K112239
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/28/2015

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: 07/31/2016
• Device Catalogue Number: SGC01ST
• Device Lot Number: 50727U310
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/23/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/03/2015
• Initial Date FDA Received: 11/23/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/22/2015; 12/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2015
• 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 Age: 80 YR
• Patient Weight: 70