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

Catalog Number 1012407-30

Device Problems Difficult To Position (1467); Difficult to Remove (1528)

Patient Problem No Patient Involvement (2645)

Event Date 01/26/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).The device was returned for analysis.The difficult to position and remove the guide wire were unable to be confirmed.Based on visual, dimensional and functional analysis of the returned device, there is no indication of a product quality issue with respect to manufacture, design or labeling.The investigation was unable to determine a conclusive cause for the reported difficulties.A review of the lot history record revealed no non-conformances.Additionally, a review of the complaint history identified no other incidents reported from this lot.Based on the information reviewed, there is no indication of a product quality issue with the respect to manufacturing, design, or labeling.

Event Description

It was reported that the procedure was to treat a lesion in the right coronary artery with heavy calcification and moderate tortuosity.A 3x30mm trek over the wire (otw) balloon dilatation catheter (bdc) was prepped/flushed prior to use.A non-abbott.014 guide wire was advanced into the backend of the trek bdc.Resistance was noted and the guide wire was not able to pass through the catheter tip.The guide wire could not be removed.Thus, the device was not used and there was no patient involvement.Multiple non-abbott balloons were able to traverse over the same guide wire.A 3.5x38mm xience alpine stent delivery system (sds) was advanced toward the target lesion and failed to cross due to the patient anatomy.There were no other device issues noted.The device was removed and replaced with a non-abbott stent to complete the procedure.There was no adverse patient effect and no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: 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: 5447488
• MDR Text Key: 38854383
• Report Number: 2024168-2016-00996
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103110
• 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
• Report Date: 02/19/2016

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: 01/31/2018
• Device Catalogue Number: 1012407-30
• Device Lot Number: 50228G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/26/2016
• Initial Date FDA Received: 02/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2015
• 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