MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC RAPIDTRANSIT 100CM; CATHETER, CONTINUOUS FLUSH

Catalog Number	601240
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).The device was discarded; therefore, no further investigation will be performed.A manufacturing record evaluation was performed for the finished device 17659684 number, and no non-conformances related to the reported complaint condition were identified.Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Initial reporter: the customer contact information, including name, occupation, phone, fax, and e-mail address, was not reported.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 company is seeking this information through the event investigation.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.
Event or Problem Description
As reported by a healthcare professional, there was resistance between a 100cm rapidtransit microcatheter (601240, 17659684) and an unknown guidewire.The microcatheter (mc) was removed from the patient¿s body and flushed.It was inserted again but the same issue continued.It was replaced with another device and the procedure was continued.The customer states there is no additional information available.
Additional Manufacturer Narrative
Product complaint (b)(4).Additional information received indicated that the devices were used and prepped as per the instructions for use.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.Complaint conclusion: as reported by a healthcare professional, there was resistance between a 100cm rapidtransit microcatheter (601240, 17659684) and an unknown guidewire.The microcatheter (mc) was removed from the patient¿s body and flushed.It was inserted again but the same issue continued.It was replaced with another device and the procedure was continued.The customer states there is no additional information available.Additional information received indicated that the devices were used and prepped as per the instructions for use.The device was not returned for analysis and therefore, no further investigation can be performed at this time.A manufacturing record evaluation was performed for the finished device (b)(4).Number, and no non-conformances related to the reported complaint condition were identified.The reported customer complaint of ¿catheter (body/shaft) - resistance/friction-inner lumen with loss of mc cerebral target position¿ could not be confirmed.Based on the device history record review, there is no indication that the event is related to the device manufacturing process.The instructions for use (ifu) caution that if unusual friction is still noticed during advancement or retraction of the coil system, verify flush lines are open and properly pressurized.Then slowly withdraw the entire catheter system and examine for damage.Replace it with a new system.If friction still exists, withdraw and examine the delivery catheter system.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and without the return of the complaint device; however, it is possible that clinical and procedural factors, including device manipulation / interaction, aneurysm size and vessel characteristics and device selection may have contributed to the reported issue.As part of the post market surveillance program, information from this complaint is trended to identify statistical signals for consideration of further correction action.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.

• Brand Name: RAPIDTRANSIT 100CM
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA 02767
• MDR Report Key: 9272102
• Report Number: 1226348-2019-01012
• Device Sequence Number: 16171615
• Product Code: KRA
• UDI-Device Identifier: 10886704028338
• UDI-Public: 10886704028338
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K972518
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2019

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: 02/29/2020
• Device Catalogue Number: 601240
• Device Lot Number: 17659684
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/14/2019
• Supplement Date Received by Manufacturer: 11/19/2019
• Initial Report FDA Received Date: 11/04/2019
• Supplement Report FDA Received Date: 12/10/2019
• 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: UNKNOWN GUIDEWIRE