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

Catalog Number	1012276-25
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/30/2018
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.Continued: a snare device was then used to retrieve the balloon from the anatomy.Another balloon was used to successfully complete the procedure.The patient remained stable during and after the procedure.There was no adverse patient sequela reported.No additional information was provided.The wiggle guide wire referenced is being filed under a separate medwatch report number.Evaluation summary: visual and functional inspections were performed on the returned device.The reported separation was confirmed.The reported difficulty removing the device could not be replicated in a testing environment as it was based on operational circumstances.The reported deflation issue could not be replicated in a testing environment due to the condition of the returned device.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 deflation issue.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 calcified right coronary artery (rca).During unpacking of the first trek balloon dilatation catheter (bdc) , it was noted that there was a kink in the dispenser hoop coil.When the device was removed, it was noted that the proximal shaft was kinked/bent.Another balloon was used to continue the procedure.However, the physician deemed it necessary to upsize on the bdc.Another trek bdc was used and advanced to the lesion with no resistance.It was inflated once at nominal pressure.During deflating, it was noted that the balloon would not deflate at all.The indeflator was then removed and a syringe was used to pull negative for 20 seconds multiple times.Blood was present in the syringe.It was thought that the balloon had ruptured.However, through a second check, the balloon was still fully inflated.The physician then decided to remove the balloon (fully inflated), when the distal shaft broke off and the balloon remained in the rca.Resistance was felt with the hi-torque wiggle guide wire (gw) during the removal of the bdc when the shaft broke.Two non-abbott gw were then used in an attempt to poke and rupture the balloon, but was unsuccessful.A second attempt was made with another non-abbott gw and a microcatheter, but was unsuccessful.Then another unspecified gw was used in an attempt to deflate the balloon, with a bovi-wire (electrical current) technique, and the balloon was successfully ruptured/deflated.
Additional Manufacturer Narrative
Internal file number: (b)(4).Initial report also sent report to fda changed from unk to yes.

• 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: 7621907
• Report Number: 2024168-2018-04706
• Device Sequence Number: 1695342
• Product Code: LOX
• UDI-Device Identifier: 08717648138591
• UDI-Public: 08717648138591
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2018

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: 05/31/2019
• Device Catalogue Number: 1012276-25
• Device Lot Number: 60624G1
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/06/2018
• Initial Date Received by Manufacturer: 05/30/2018
• Supplement Date Received by Manufacturer: 07/16/2018
• Initial Report FDA Received Date: 06/20/2018
• Supplement Report FDA Received Date: 07/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDE WIRE: WIGGLE WIRE SHEATH: 6FR; GUIDE WIRE: WIGGLE WIRE SHEATH: 6FR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 185