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

Model Number	1012448-15
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned to abbott vascular for analysis.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 reported from this lot.Factors that may contribute to difficulty removing the protective sheath may include, but not limited to, normal variation within the manufacturing process, protective sheath removal technique, damage during manufacturing, damage to the protective sheath, an undersized sheath and/or an oversized balloon profile and stent, mishandling or positive pressure applied during preparation.To ensure this type of issue is not the result of a manufacturing quality issue, all products are 100% visually inspected for damage.Additionally, a sampling of units is destructively tested to verify proper balloon/stent profiles.The investigation was unable to determine a conclusive cause for the reported difficulty to remove the protective sheath.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.
Event or Problem Description
It was reported that resistance was felt during removal of the protective sheath from the 2.75 x 15mm nc trek balloon dilation catheter.The bdc was not used and was replaced with a new nc trek bdc.There was no patient involvement and no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: NC TREK CORONARY DILATATION CATHETE
• Common Device Name: CORONARY DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10551519
• Report Number: 2024168-2020-07828
• Device Sequence Number: 3528481
• Product Code: LOX
• UDI-Device Identifier: 08717648151828
• UDI-Public: 08717648151828
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K103153
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/17/2020

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: 02/28/2022
• Device Model Number: 1012448-15
• Device Catalogue Number: 1012448-15
• Device Lot Number: 90320G1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/31/2020
• Initial Report FDA Received Date: 09/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1