MAUDE Adverse Event Report: ABBOTT VASCULAR NC TREK CORONARY DILATATION CATHETER

Model Number	1012452-12
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Na.
Event or Problem Description
It was reported that during prep, the 3.75x12 mm trek balloon dilatation catheter bubbles were noted when negative pressure was applied.Due to the bubbles present it was decided to inflate the device to see if there was a leak.A pin sized hole was noted as the source of the leak.The device was not used and there was no patient involvement.A new trek bdc was used to complete the procedure.There was no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Product performance engineering reviewed the incident information; however, the prrecord identified no manufacturing nonconformities issued to the reported loduct was not returned to abbott vascular for analysis.A review of the lot history ot that would have contributed to this event.Additionally, a review of the complaint history identified no other similar incidents reported from this lot.Possible factors that may contribute to balloon leaks may include, but are not limited to, manufacturing, damage to the balloon during unpacking, incorrect prep, or balloon inflation prior to soaking.The investigation was unable to determine a conclusive cause for the reported balloon leak.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: NC TREK CORONARY DILATATION CATHETER
• Common Device Name: CORONARY DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11143610
• Report Number: 2024168-2021-00275
• Device Sequence Number: 16312782
• Product Code: LOX
• UDI-Device Identifier: 08717648152023
• UDI-Public: 08717648152023
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K103153
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2023
• Device Model Number: 1012452-12
• Device Catalogue Number: 1012452-12
• Device Lot Number: 00617G1
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/21/2020
• Supplement Date Received by Manufacturer: 01/13/2021
• Initial Report FDA Received Date: 01/09/2021
• Supplement Report FDA Received Date: 01/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1