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

Catalog Number SGC01ST

Device Problems Loose or Intermittent Connection (1371); Physical Property Issue (3008)

Patient Problem No Patient Involvement (2645)

Event Date 07/15/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 that the stopcock could not connect to the steerable guide catheter (sgc) flush port.If this were to recur when the device was in the anatomy, there is potential for an air leak which can cause or contribute to patient injury.It was reported that during device preparation of the sgc, it was not possible to connect the high pressure three way stopcock into the flush port of the sgc.Three stopcocks were attempted unsuccessfully.The flush port appeared different.Another sgc was used successfully in the procedure.There was no patient involvement or a clinically significant delay in procedure reported.There was no additional information provided.

Manufacturer Narrative

(b)(4).Evaluation summary: the device returned for analysis.The irregular appearance was confirmed due to a broken stopcock luer lodged inside the flush port.However, returned device analysis could not confirm the reported loose/intermittent connection.A review of the lot history record revealed no manufacturing nonconformities.Additionally, a review of the complaint history identified no other incidents reported from this lot.All available information was investigated and the reported loose/intermittent connection may be attributed to variation in the non-abbott stopcocks used at the account; however, this cannot be definitively confirmed.The irregular appearance was determined to be related to the observed broken stopcock luer in the flush port.It is likely that the stopcock luer broke off during attempts to thread the stopcock onto the device.Based on the information reviewed, there is no indication of a product quality issue with respect to design, manufacture, or labeling of the device.

• 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: 5854972
• MDR Text Key: 51869280
• Report Number: 2024168-2016-05235
• 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
• Report Date: 08/31/2016

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: 03/31/2017
• Device Catalogue Number: SGC01ST
• Device Lot Number: 60330U142
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/15/2016
• Initial Date FDA Received: 08/08/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/31/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2016
• 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