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

Catalog Number	1012448-15
Medical Device Problem Codes	Deflation Problem (1149); Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/12/2019
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 customer reported the device was discarded.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.Na.
Event or Problem Description
It was reported that a 2.75 x 15 mm nc trek balloon dilatation catheter (bdc) was advanced for post-dilatation of an unspecified stent.After the balloon was inflated once to 10 atmospheres, the balloon partially deflated, which resulted in resistance with an unspecified guiding catheter during removal.After several attempts, the balloon was withdrawn independently and ultimately deflated.An unspecified bdc was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
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 deflation issue; however, the reported difficulty removing the device appears to be related to circumstances of the procedure.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.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.

• Brand Name: NC TREK RX
• Common Device Name: CORONARY DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 8879976
• Report Number: 2024168-2019-10706
• Device Sequence Number: 1948533
• Product Code: LOX
• UDI-Device Identifier: 08717648151828
• UDI-Public: 08717648151828
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K103153
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2019

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: 09/30/2021
• Device Catalogue Number: 1012448-15
• Device Lot Number: 81031G1
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/19/2019
• Supplement Date Received by Manufacturer: 08/21/2019
• Initial Report FDA Received Date: 08/09/2019
• Supplement Report FDA Received Date: 09/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1