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

Catalog Number 1012449-08

Device Problems Material Separation (1562); Deformation Due to Compressive Stress (2889); Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/29/2018

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 is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all relevant information.

Event Description

It was reported that the procedure was to treat a heavily tortuous unspecified coronary artery.A 3.0 x 8 mm nc trek balloon dilatation catheter (bdc) was used.However, the device was manipulated throughout the procedure due to tortuosity and calcification.Therefore, the device became kinked in several places and the distal shaft separated outside of the anatomy after it was removed.The device did not meet any resistance with the introducer sheath during removal.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).It was initially reported that the device would be returned for analysis.Subsequent information revealed that the device was discarded and is not available for evaluation.The product was not returned to abbott vascular for analysis.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no other similar incidents from this lot.The investigation determined the reported difficulties of physical resistance, kinks and hypotube separation appear to be related to circumstances of the procedure.Based on the reported information, the balloon catheter encountered resistance with the heavily tortuous and calcified anatomy causing the reported resistance.Manipulation and/or inadvertent mishandling of the device during advancement through the anatomy caused the hypotube to kink at multiple location ultimately resulting in the reported separation.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Manufacturer Narrative

(b)(4).Device status updated from not returning to returned.A visual inspection was performed on the returned device and the tip separation was unable to be confirmed.The reported kinks were confirmed.The reported physical resistance was unable to be replicated in a testing environment as it was based on operational circumstances a review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no other similar incidents from this lot.The investigation determined the reported/noted difficulties of physical resistance, kinks and separation appear to be related to circumstances of the procedure.Based on the reported information, the balloon catheter encountered resistance with the heavily tortuous and calcified anatomy causing the reported resistance.Manipulation and/or inadvertent mishandling of the device during advancement through the anatomy caused the hypotube to kink at multiple location ultimately resulting in the reported separation outside the anatomy.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: NC 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: 7885163
• MDR Text Key: 120559418
• Report Number: 2024168-2018-07240
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• PMA/PMN Number: K110134
• 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,Followup
• Report Date: 12/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Catalogue Number: 1012449-08
• Device Lot Number: 80525G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2018
• Date Manufacturer Received: 12/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1