MAUDE Adverse Event Report: ABBOTT VASCULAR TREK CORONARY DILATATION CATHETER

Model Number	1012276-12
Medical Device Problem Codes	Failure to Fold (1255); Material Rupture (1546); Material Separation (1562); Stretched (1601)
Health Effect - Clinical Codes	Angina (1710); Non specific EKG/ECG Changes (1817)
Date of Event	01/12/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the procedure was to treat an 80% stenosed and calcified lesion located in the proximal ramus and left anterior descending coronary arteries.The trek rx balloon was advanced to the lesion.During the first inflation at 8 atmospheres, the balloon ruptured and the shaft separated.The patient experienced chest pain and st elevation, which was treated with medication.The complete device was easily removed in one piece.The balloon appeared elongated and thinner than normal.A xience sierra stent was implanted and the patient recovered without sequela.No additional information was provided.
Additional Manufacturer Narrative
Visual, functional and scanning electron microscopy (sem) inspections/analysis were performed on the returned device.The reported failure to fold (balloon folded back on itself) and separation were confirmed; however, the reported stretched (elongated) balloon could not be confirmed.However, it was noted that the outer member was stretched and wrinkled, proximal to the proximal seal.There were multiple locations of outer member stretching.The inner member was stretched on its entire length.Due to the stretching of outer member and inner member, the proximal seal moved over the proximal balloon marker.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/complaints from this lot.The reported patient effect of angina is listed in the coronary dilatation catheters (cdc), trek rx and mini trek rx, global, instructions for use (ifu) as a known patient effect.It is possible that the noted stretching on the device was likely due to inadvertent mishandling of the device; however, a conclusive cause cannot be determined.In addition, it is possible that the account perceived the balloon folded distally over itself, over the distal seal, and over the distal tip as the reported elongated/stretched balloon; however, a conclusive cause cannot be determined since the reported complaint was not confirmed during return analysis.The investigation was unable to determine a conclusive cause for the reported complaints.The reported therapy/non-surgical treatment/ delayed and treatment with medication appear to be related to circumstances of the procedure.A conclusive cause for the reported patient effects of angina and st elevation (ekg/ecg changes) and the relationship to the device, if any, cannot be determined.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.(b)(4).
Event or Problem Description
Subsequent to the previously filed report, the following information was received: the balloon folded back on itself and did not rupture.No additional information was provided.

• Brand Name: 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: 11267785
• Report Number: 2024168-2021-00801
• Device Sequence Number: 4532115
• Product Code: LOX
• UDI-Device Identifier: 08717648138560
• UDI-Public: 08717648138560
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K103110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2021

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: 05/31/2023
• Device Model Number: 1012276-12
• Device Catalogue Number: 1012276-12
• Device Lot Number: 00610G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2021
• Initial Date Received by Manufacturer: 01/12/2021
• Supplement Date Received by Manufacturer: 03/08/2021
• Initial Report FDA Received Date: 02/02/2021
• Supplement Report FDA Received Date: 03/26/2021
• 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