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

Catalog Number 1012451-15

Device Problem Sticking (1597)

Patient Problem Ischemia (1942)

Event Date 04/28/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical devices: dil cath, guide wire; inflation; guide cath; rhv; sheath; atherectomy; power (volts); stent; other electrical; other; vessel closure; embolic protection; clip delivery system.(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.

Event Description

It was reported that the procedure was to treat the left anterior descending artery.A 3.0 x 29 mm unspecified stent was implanted; however, it was not well apposed to the vessel wall.Therefore, a 3.5 x 15 mm nc trek balloon dilatation catheter (bdc) was used for post dilatation.However, the balloon became stuck with the stent struts, which resulted in coronary ischemia.The physician inflated and deflated the balloon repeatedly until the bdc was removed.Another unspecified bdc was then used for dilation.There was no adverse patient sequela reported.No additional information was provided.

Manufacturer Narrative

(b)(4).Correction: patient identifier.Correction: the date received by mfr.Date was filed incorrectly on the initial medwatch report as 12/18/2017, but should have been 11/12/2017.(b)(4).

Manufacturer Narrative

Internal file number - (b)(4).The device was not returned for analysis.A review of the lot history record and complaint history of the reported lot could not be conducted because the lot number was not provided.The investigation was unable to determine a conclusive cause for the reported difficulty removing the balloon; however, the reported patient effect appears to be related to circumstances of the procedure.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.

• 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): ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168; 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: 7196005
• MDR Text Key: 97880365
• Report Number: 2024168-2018-00410
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K110134
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 1012451-15
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 62 YR