MAUDE Adverse Event Report: ABBOTT VASCULAR TREK CORONARY DILATATION CATHETER

Model Number	1012278-15
Medical Device Problem Codes	Deflation Problem (1149); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/17/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the left anterior descending coronary artery.A 3.5x23mm xience sierra stent was implanted, and a 4x15mm trek balloon dilatation catheter (bdc) was used for post-dilatation.The balloon could only partially deflate, and the bdc could not be inserted into the introducer sheath.The entire system was removed together.The patient experienced thoracic pain, and morphine was used as treatment.There were no adverse patient sequelae and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
H6: medical device problem code: 2017/incorrect prep.Visual, functional and scanning electron microscopy (sem) inspections/analysis were performed on the returned device.The reported tear on the tip and shaft were confirmed.The reported deflation issue and difficulty removing the device could not be replicated in a testing environment due to the condition of the returned device.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 and/or complaints from this lot.It was reported that the device was prepped inside the anatomy.It should be noted that the coronary dilatation catheters (cdc), trek rx and mini trek rx, global instructions for use (ifu), specifies: all air must be removed from the balloon and displaced with contrast prior to inserting into the body, otherwise, complications may occur.In this case, it is unknown if the ifu violation caused or contributed to the reported complaint.The investigation was unable to determine a conclusive cause for the reported deflation issue; however, the reported difficulty removing the device, tears in the tip and shaft and medication appears to be related to operational context.A conclusive cause for the reported patient effect of pain and the relationship to the product, 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.
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the left anterior descending coronary artery.A 3.5x23mm xience sierra stent was implanted, and a 4x15mm trek balloon dilatation catheter (bdc) was used for post-dilatation.The balloon could only partially deflate, and the bdc could not be inserted into the introducer sheath.The entire system was removed together.The patient experienced thoracic pain, and morphine was used as treatment.There were no adverse patient sequelae and no clinically significant delay in the procedure.Subsequent to the initially filed report, the following information was received: tears in the tip and outer member were noted on the device when the balloon was retrieved into the guiding catheter.Additionally, the device was aspirated in the anatomy, as opposed to outside the anatomy.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: 12103617
• Report Number: 2024168-2021-05657
• Device Sequence Number: 20014537
• Product Code: LOX
• UDI-Device Identifier: 08717648138713
• UDI-Public: 08717648138713
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2021

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: 08/31/2022
• Device Model Number: 1012278-15
• Device Catalogue Number: 1012278-15
• Device Lot Number: 90925G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2021
• Initial Date Received by Manufacturer: 06/17/2021
• Supplement Date Received by Manufacturer: 09/22/2021
• Initial Report FDA Received Date: 07/01/2021
• Supplement Report FDA Received Date: 09/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 3.5X23MM XIENCE SIERRA STENT
• Outcome Attributed to Adverse Event: Other; Required Intervention