MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC PROWLER SELECT MICROCATHETERS; CATHETER, CONTINOUS FLUSH

Catalog Number	606S155X
Medical Device Problem Code	Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/09/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be submitted within 30 days of receipt.This is 1 of 2 mdr reports submitted for this event, with associated report numbers of 3008264254-2017-00103 and 2954740-2017-00191.
Event or Problem Description
As reported by a healthcare professional, during basilar artery aneurysm coiling, a galaxy g2 coil (641cf0412/s12782) could not be pushed in the prowler lpes microcatheter (606s155x/17161634).The coil was removed with the microcatheter.The g2 did not appear damaged.There was no patient injury or significant delay in the procedure.They completed the procedure with another microcatheter and coil.It was reported that the product would be returned for analysis.
Additional Manufacturer Narrative
Dhr completed on (b)(6) 2017: a review of the manufacturing documentation associated with this lot 17161634 presented no issues during the manufacturing or inspection process that can be related to the reported complaint.Additional information will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
Conclusion: as reported by a healthcare professional, during basilar artery aneurysm coiling, a galaxy g2 coil (641cf0412/s12782) could not be pushed in the prowler lpes microcatheter (606s155x/17161634).The coil was removed with the microcatheter.The g2 did not appear damaged.There was no patient injury or significant delay in the procedure.They completed the procedure with another microcatheter and coil.It was reported that the product would be returned for analysis.The prowler lpes was not available for analysis.A review of the manufacturing documentation associated with this lot 17161634 presented no issues during the manufacturing or inspection process that can be related to the reported complaint.The resistance within the microcatheter could not be confirmed without product return for analysis.The root cause of the event could not be determined; however, procedural/handling factors may have contributed to the event.There is no current safety signal identified related to the reported event based on review of complaint history for the device.Since there was no evidence to suggest the event was related to a manufacturing issue, no corrective actions will be taken at this time.

• Brand Name: PROWLER SELECT MICROCATHETERS
• Common Device Name: CATHETER, CONTINOUS FLUSH
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA
• MDR Report Key: 6687112
• Report Number: 3008264254-2017-00103
• Device Sequence Number: 1078105
• Product Code: KRA
• UDI-Device Identifier: 10886704028802
• UDI-Public: (01)10886704028802(17)171231(10)17161634
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K021591
• 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,Followup,Followup
• Report Date (Section B): 06/10/2017

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: 12/31/2017
• Device Catalogue Number: 606S155X
• Device Lot Number: 17161634
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/10/2017
• Supplement Date Received by Manufacturer: 07/20/2017; 09/04/2017
• Initial Report FDA Received Date: 07/05/2017
• Supplement Report FDA Received Date: 08/14/2017; 09/04/2017
• Patient Sequence Number: 1