MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC (MIRAMAR) ASCENT REMODELBALLOON 6X9; CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY

Catalog Number	BRS00060900
Medical Device Problem Code	Torn Material (3024)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Information regarding patient age, gender, weight, race, ethnicity, and medical history were not provided.Initial reporter information such as phone and email address are unknown.[conclusion]: the healthcare professional reported that the ascent remodel balloon catheter 6 x 9 (brs00060900 / lot number not available) became kinked during the procedure.The physician replaced the balloon catheter and the procedure was successfully completed.There was no report of patient injury or complication.Investigation summary: there is a kink in the catheter approximately 95 cm from the proximal end.The outer member of the catheter is split and separated between approximately 94 cm and 95 cm from the proximal end.There are also bends in the catheter approximately 132 cm and 133 cm from the proximal end.Damage at the edges of the outer member where it is split suggests that the outer member tore and pulled away from the support coil.The lot number of the device is unknown.Without the lot number, manufacturing information cannot be reviewed.Investigation conclusion: the complaint that the device is kinked or bent is confirmed.The catheter is kinked and damaged approximately 94 to 95 cm from the proximal end.Bending of the catheter approximately 132 to 133 cm from the proximal end appears to be incidental, and possibly related to coiling the device for return.The outer member of the catheter is split and pulled apart at the principal kink.Damage to the ends of the split suggest that the outer member tore, possibly due to the application of excessive force.The circumstances surrounding the reported event are unknown, so the cause of the damage to the outer member cannot be identified.However, 100% of devices are inspected in-process for obvious damage.In addition, 100% of devices are inspected after hydrophilic coating.After this inspection, the devices are placed in protective packaging hoops.Thus, it is very unlikely that the device left the manufacturing facility with the observed damage.As part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective/preventive action may be triggered at a later time.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no corrective actions will be taken at this time.Missing information from this report is identified as blank; this information was not provided in the reported event or available at the time of report submission.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.
Event or Problem Description
The healthcare professional reported that the ascent remodel balloon catheter 6 x 9 (brs00060900 / lot number not available) became kinked during the procedure.The physician replaced the balloon catheter and the procedure was successfully completed.There was no report of patient injury or complication.

• Brand Name: ASCENT REMODELBALLOON 6X9
• Common Device Name: CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC (MIRAMAR); 3260 executive way; miramar 33025
• MDR Report Key: 7592951
• Report Number: 3008114965-2018-00646
• Device Sequence Number: 2066970
• Product Code: MJN
• UDI-Device Identifier: 00878528001935
• UDI-Public: 00878528001935
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K103780
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 06/08/2018

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 Catalogue Number: BRS00060900
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2018
• Initial Date Received by Manufacturer: 06/08/2018
• Initial Report FDA Received Date: 06/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1