MAUDE Adverse Event Report: ABBOTT VASCULAR TREK RX CORONARY DILATATION CATHETER

Catalog Number	1012274-08
Medical Device Problem Codes	Inflation Problem (1310); Leak/Splash (1354); Material Rupture (1546)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/31/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
G9: exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.The device is expected to be returned for investigation.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 a 3.0x8mm trek rx balloon dilatation catheter (bdc) was being prepared per the instructions for use; however, a leak was noted during an attempt to pull negative pressure.Pressure was applied and the leak was confirmed.The bdc was not used and there was no patient involvement.The procedure was successfully completed with a new 3.0x8mm trek balloon dilatation catheter.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Exemption number e2019001.Visual inspection was performed on the returned device.The balloon rupture was not confirmed; however, the noted tear in the outer member is likely what was perceived as the rupture since the balloon dilatation catheter would not hold pressure.The reported leak and inflation issue could not be replicated in a testing environment due to the condition of the returned device.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/complaints from this lot.The investigation was unable to determine a conclusive cause for the reported complaints.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.
Event or Problem Description
Additional information received stating: after the leak was noted during an attempt to pull negative pressure, an attempt to inflate the balloon outside of the patient anatomy was made.At this time it was noted that saline or contrast was coming out drop by drop and the balloon failed to inflate.No additional information was provided.

• Brand Name: TREK RX CORONARY DILATATION CATHETER
• Common Device Name: CORONARY DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 8922531
• Report Number: 2024168-2019-11075
• Device Sequence Number: 2471553
• Product Code: LOX
• UDI-Device Identifier: 08717648138416
• UDI-Public: 08717648138416
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K103110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2019
• Device Catalogue Number: 1012274-08
• Device Lot Number: 60826G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2019
• Initial Date Received by Manufacturer: 07/31/2019
• Supplement Date Received by Manufacturer: 11/21/2019
• Initial Report FDA Received Date: 08/22/2019
• Supplement Report FDA Received Date: 12/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1