MAUDE Adverse Event Report: AV-TEMECULA-CT NC TREK CORONARY DILATATION CATHETER

Catalog Number 1012448-12

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/16/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The customer reported the device was discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was to treat an obtuse marginal artery.The procedure was performed on 09/16/2016.Pre-dilatation was performed with a 2.5 x 12 mm nc trek balloon catheter.A 2.5 x 12 mm absorb gt1 scaffold was implanted and post-dilatation was performed with a 2.75 x 12 mm nc trek balloon catheter.The patient returned to the hospital on (b)(6) 2016 with stomach pain.Angiography confirmed that the scaffold was patent with no issues.However, when reviewing the index procedure films, it was noticed that the 2.75 x 12 mm nc trek balloon that was used for post-dilatation was actually a 2.75 x 15 mm balloon.The film showed that the balloon markers of the nc trek were both 1 or 2 mm longer than the scaffold markers.There was no clinically significant delay in procedure and no adverse patient effects.No additional information was provided.

Manufacturer Narrative

(b)(4).The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other similar incidents from this lot.The investigation was unable to determine a conclusive cause for the reported difficulty.A cine was received and reviewed by an abbott vascular clinical specialist.The cine analysis concluded the image shows the absorb markers with the balloon markers clearly outside of the scaffold markers on either side.As the working length of the balloon can be approximately 10-14 mm, it is possible that this balloon is within specification but on the longer side of the acceptable range.The balloon is not measured within the cine by any radiographic tools.In this case, since the device was not returned for analysis a definite cause for the reported complaint cannot be determined.Based on the information reviewed, there is no indication of a product quality issue.

Manufacturer Narrative

(b)(4).An additional cine review was performed by an abbott vascular clinical specialist who concluded the following: there does not appear to be an issue with the pre-dil nc balloon dilatation catheter (bdc), the absorb delivery or deployment, or the post dilatation nc bdc.There is no product issue.The nc bdc used for post dilatation does appear to be longer than the deployed scaffold and it appears that the operator requested a 12mm bdc and was given a 15mm bdc in error.In this case, since the device was not returned for analysis a definite cause for the reported complaint cannot be determined.

• Brand Name: NC TREK CORONARY DILATATION CATHETER
• Type of Device: CORONARY DILATATION CATHETER
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer (Section G): EL COYOL, COSTA RICA REG# 3009031392; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 6035587
• MDR Text Key: 57695064
• Report Number: 2024168-2016-07030
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110134
• 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,Followup,Followup
• Report Date: 04/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Catalogue Number: 1012448-12
• Device Lot Number: 60607G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2016
• 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
• Patient Age: 75 YR
• Patient Weight: 129