MAUDE Adverse Event Report: ABBOTT VASCULAR TREK CORONARY DILATATION CATHETER

Model Number	1012278-15
Medical Device Problem Codes	Material Separation (1562); Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for evaluation.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.The investigation was unable to determine a conclusive cause for the reported failure to deflate.However, factors that may contribute to difficulty deflating the balloon may include, but are not limited to, deflation technique, contrast concentration, tortuous anatomy, loose connection with the indeflator, contamination in the inflation lumen or damage to the guide wire and/or inflation lumen.The reported separation, additional treatment and removal of foreign body appear to be related to circumstances of the procedure as the shaft separated since the balloon remained inflated during attempts to remove the device.Additional treatment was performed in an attempt to retrieve the balloon via lasso, the balloon was intentionally crushed with the lasso and thus partially deflated and ultimately retrieved through the left radial artery.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that the procedure was to treat a left anterior descending artery (lad) with a kissing technique.A 2.5x23mm xience stent was in the diagonal artery and a 4x15mm trek balloon was in the lad.There was no resistance when advancing both devices in the non-abbott guiding catheter.The stent was implanted without issue and the stent delivery system was removed.The trek balloon was inflated once at nominal pressure without issue.However, after the kissing technique was used, the trek balloon completely failed to deflate.The balloon remained inflated at the distal part of the guiding catheter and when pulling it in the shaft separated.In an attempt to retrieve the balloon via lasso, the balloon was intentionally crushed with the lasso and thus partially deflated and ultimately retrieved through the left radial artery.There were no adverse patient effects and no clinically significant delay.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: 12512542
• Report Number: 2024168-2021-08434
• Device Sequence Number: 20127179
• 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
• Report Date (Section B): 09/22/2021

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: 10/31/2022
• Device Model Number: 1012278-15
• Device Catalogue Number: 1012278-15
• Device Lot Number: 91129G1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/06/2021
• Initial Report FDA Received Date: 09/22/2021
• 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: 7F SHEATH; EBU 3.5 6F MEDTRONIC GUIDING CATHETER; XIENCE 2.5X23MM
• Outcome Attributed to Adverse Event: Required Intervention