MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC PROWLER SELECT PLUS 150/15CM; CATHETER, CONTINOUS FLUSH

Catalog Number	606S252
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).[conclusion]: the healthcare professional reported that the issue related to the prowler select plus, 150cm x 15cm, 1 marker (606s252/17381139) occurred during the coil embolization procedure of an acute stage brain infarction at the middle cerebral artery (mca).During the thrombus removal step of the procedure, the prowler select plus microcatheter was used with a guidewire (chikai, asahi intecc) when resistance was felt with the guidewire.The prowler select plus was confirmed to be partially crushed in the body/shaft of the microcatheter.The resistance experienced with the guidewire was a result of the partially obstructed/crushed portion on the microcatheter.The microcatheter was replaced and the procedure was successfully completed without further issues or delay.There was no report of patient injury or complication; the complaint product was new and was stored per labeling instructions.The procedure was conducted in accordance with the instruction for use (ifu) with constant flush maintained at all time.There was no visible defect or damage noted on the product prior to the event.The prowler select plus microcatheter is not available to be returned for evaluation and testing.Based on complaint information, the device was not available to be returned for analysis.A review of manufacturing documentation associated with this lot (17381139) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no non-conformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.Product analysis cannot be conducted as the product was not returned for analysis.No determination of causes and possible contributing factors could be made.As such, the investigation will be closed.With the information provided in the complaint and without the product available for analysis, the reported issue by the customer cannot be confirmed.Based on the device history record review, there is no indication that the event is related to the device manufacturing process.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and without the return of the complaint sample; however, it is possible that clinical and procedural factors, including device manipulation/interaction, aneurysm size/vessel characteristics, device selection, and the concomitant microcatheter, may have contributed to the reported related to the prowler select plus microcatheter that had a partial obstructed/ crushed portion on its body/shaft that resulted in the guidewire being met with resistance.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 issue related to the prowler select plus, 150cm x 15cm, 1 marker (606s252/17381139) occurred during the coil embolization procedure of an acute stage brain infarction at the middle cerebral artery (mca).During the thrombus removal step of the procedure, the prowler select plus microcatheter was used with a guidewire (chikai, asahi intecc) when resistance was felt with the guidewire.The prowler select plus was confirmed to be partially crushed in the body/shaft of the microcatheter.The resistance experienced with the guidewire was a result of the partially obstructed/crushed portion on the microcatheter.The microcatheter was replaced and the procedure was successfully completed without further issues or delay.There was no report of patient injury or complication; the complaint product was new and was stored per labeling instructions.The procedure was conducted in accordance with the instruction for use (ifu) with constant flush maintained at all time.There was no visible defect or damage noted on the product prior to the event.The prowler select plus microcatheter is not available to be returned for evaluation and testing.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr is to include the additional event information received on 1/6/2019.The initial reporter title, first and last names were added.The initial reporter phone: (b)(6).[conclusion]: the healthcare professional reported that the issue related to the prowler select plus, 150cm x 15cm, 1 marker (catalog #: 606s252/lot #: 17381139) occurred during the coil embolization procedure of an acute stage brain infarction at the middle cerebral artery (mca).During the thrombus removal step of the procedure, the prowler select plus microcatheter was used with a guidewire (chikai, asahi intecc) when resistance was felt with the guidewire.When the guidewire was inserted into the microcatheter, that was when the resistance was reported to be experienced.The prowler select plus was crushed in the body/shaft of the microcatheter.The resistance experienced with the guidewire was a result of the partially obstructed/crushed portion on the microcatheter.It was confirmed that prior to use, concomitant devices used did not have any kink or bent on them.Adequate and continuous flush was reported to be maintained through the catheter.The microcatheter was replaced and the procedure was successfully completed without further issues or delay.There was no report of patient injury or complication; the complaint product was new and was stored per labeling instructions.The procedure was conducted in accordance with the instruction for use (ifu) with constant flush maintained at all time.There was no visible defect or damage noted on the product prior to the event.The prowler select plus microcatheter is not available to be returned for evaluation and testing.Based on complaint information, the device was not available to be returned for analysis.A review of manufacturing documentation associated with this lot (17381139) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no non-conformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.Product analysis cannot be conducted as the product was not returned for analysis.No determination of causes and possible contributing factors could be made.As such, the investigation will be closed.With the information provided in the complaint and without the product available for analysis, the reported issue by the customer cannot be confirmed.Based on the device history record review, there is no indication that the event is related to the device manufacturing process.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and without the return of the complaint sample; however, it is possible that clinical and procedural factors, including device manipulation/interaction, aneurysm size/vessel characteristics, device selection, and the concomitant microcatheter, may have contributed to the reported related to the prowler select plus microcatheter that had a partial obstructed/crushed portion on its body/shaft that resulted in the guidewire being met with resistance.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.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.

• Brand Name: PROWLER SELECT PLUS 150/15CM
• Common Device Name: CATHETER, CONTINOUS FLUSH
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA 02767
• MDR Report Key: 8139805
• Report Number: 1226348-2018-00775
• Device Sequence Number: 11198831
• Product Code: KRA
• UDI-Device Identifier: 10886704028819
• UDI-Public: 10886704028819
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2018

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 Expiration Date: 11/30/2018
• Device Catalogue Number: 606S252
• Device Lot Number: 17381139
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/19/2018
• Supplement Date Received by Manufacturer: 01/06/2019
• Initial Report FDA Received Date: 12/06/2018
• Supplement Report FDA Received Date: 01/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1