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

Catalog Number 1012276-12

Device Problems Material Separation (1562); Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Patient Involvement (2645)

Event Date 04/08/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was received.The investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that before use of a 3.50x12mm trek balloon dilatation catheter, the packaging was noted as defective.Therefore, the device was not used and there was no patient involvement.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.Device analysis of the returned device noted that the hypotube was separated.

Manufacturer Narrative

Internal file number: (b)(4).Evaluation summary: a visual inspection was performed on the returned device and the hypotube was noted to be separated.The reported complaint was confirmed.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 complaint.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.

• 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
• MDR Report Key: 8637935
• MDR Text Key: 146075738
• Report Number: 2024168-2019-04075
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• PMA/PMN Number: K103110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 07/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Catalogue Number: 1012276-12
• Device Lot Number: 90215G1
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/02/2019
• Date Manufacturer Received: 06/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1