MAUDE Adverse Event Report: ABBOTT VASCULAR STEERABLE GUIDE CATHETER; VALVE REPAIR

Catalog Number SGC0302

Device Problems Positioning Failure (1158); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/16/2019

Event Type  malfunction  

Manufacturer Narrative

Exemption number (b)(4) permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.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.Na.

Event Description

This is being filed to report the inability to straighten the sgc tip.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4+.During preparation of the first clip delivery system (cds), the clip introducer was noted to be slightly dented; therefore, the cds was put aside.A second cds was prepared but a slight dent was noted on the clip introducer, too.The physician decided to use both devices as they were not broken.The steerable guide catheter (sgc) was placed and the first cds was inserted without issues, but the sgc minus knob didn¿t work during positioning of the clip.The minus knob was turned but the sgc didn¿t move straight.The sgc felt unusual and a sound was noted during insertion.Therefore, the sgc and cds were removed from the patient anatomy.A second sgc and the second cds were used and the clip was implanted without issue.A third cds ((b)(4)) was used and the clip was implanted successfully.Two clips were implanted, reducing mr to 1-2.There was no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The cable break resulting in positioning failure issues of steerable guide catheter (unable to straighten) observed via returned device analysis.The reported noise could not be replicated in the testing environment as the event was a symptom of the cable break.A review of the lot history record revealed no manufacturing nonconformities reported to this lot.Additionally, a review of the complaint history identified no other incidents reported from this lot.The investigation determined that the reported noise and positioning failure issues (unable to straighten guide) were a result of the cable break; however, a definitive cause for the cable break could not be definitively determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.Exemption number (b)(4) -permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There maybe gaps in numbering for reports submitted during the transition period.

• Brand Name: STEERABLE GUIDE CATHETER
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 8869721
• MDR Text Key: 153675667
• Report Number: 2024168-2019-10631
• 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
• Type of Report: Initial,Followup
• Report Date: 09/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/09/2020
• Device Catalogue Number: SGC0302
• Device Lot Number: 90109U107
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2019
• Date Manufacturer Received: 08/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CLIP DELIVERY SYSTEM
• Patient Age: 56 YR
• Patient Weight: 65