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

Catalog Number	1012448-06
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Information (3190)
Date of Event	07/15/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Evaluation summary: visual inspection was performed on the returned device.A balloon separation was noted during return analysis.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.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The investigation was unable to determine a conclusive cause for the noted separation issues.
Event or Problem Description
The 2.75 x 6 mm nc trek balloon catheter was received at abbott vascular in a biohazard bag with no information.Follow-up was attempted, but the cath lab stated that they were unaware of anything concerning this device or it's return.Return device analysis revealed the balloon catheter had blood and contrast visible in the inflation lumen, indicating its use in the patient anatomy.The distal shaft was separated and was not returned.As no information is available regarding the location of the distal portion of the catheter, it cannot be confirmed if the separation occurred inside the patient and possibly remains in the patient.

• Brand Name: NC 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: 5926755
• Report Number: 2024168-2016-05906
• Device Sequence Number: 1230256
• Product Code: LOX
• UDI-Device Identifier: 08717648151798
• UDI-Public: (01)08717648151798(17)180831(10)50923G1
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K110134
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/02/2016

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: 08/31/2018
• Device Catalogue Number: 1012448-06
• Device Lot Number: 50923G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2016
• Initial Report FDA Received Date: 09/02/2016
• 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: Other