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

Catalog Number	1012278-15
Health Effect - Clinical Code	Vessel Or Plaque, Device Embedded In (1204)
Date of Event	11/22/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Failure to follow steps/instructions.The device was not returned for evaluation.It should be noted the coronary dilatation catheters, trek rx global, information for use, states: do not torque the catheter more than one (1) full turn.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 incidents from this lot.The investigation determined the reported separation, balloon damage (twisted), entrapment of the device, physical resistance and patient effects of device embedded, additional treatment and delay appear 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.
Event or Problem Description
It was reported that the procedure was to treat a heavily tortuous and calcified saphenous vein graft (svg) to diagonal lesion.Several sheaths were used as it was difficult to access the lesion.Resistance was met during advancement of the 4.0x15 rx trek balloon dilatation catheter (bdc) to the lesion, requiring the device to be torqued several times.The balloon was inflated twice, once at 2 atmospheres (atm) for 10 seconds, and 6 atm for 20 seconds.As the bdc was pulled back, resistance was met and a 3mm portion of the balloon separated.A xience alpine stent was implanted, embedding the separated portion of the balloon in the target lesion.The physician believed that the balloon became twisted during the torqueing of the device, resulting in the tip becoming entrapped in the lesion.There was clinically significant delay during the procedure due to the device issues.No additional information was provided.

• Brand Name: TREK CORONARY DILATATION CATHETER
• Common Device Name: CORONARY DILATATION CATHETER
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 7127081
• Report Number: 2024168-2017-09858
• Device Sequence Number: 19302790
• Product Code: LOX
• UDI-Device Identifier: 08717648138713
• UDI-Public: 08717648138713
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K103110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 12/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2018
• Device Catalogue Number: 1012278-15
• Device Lot Number: 50321G1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2017
• Initial Report FDA Received Date: 12/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 48 YR
• Patient Weight: 92