MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC PROWLER PLUS 150/20CM DUAL MRK; CATHETER, CONTINOUS FLUSH

Catalog Number	6062510X
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's reference #: (b)(4).Information regarding patient identifier, date of birth, weight, race, ethnicity, and medical history were not provided.Reporter: the name, phone and email address of the initial reporter are not available / reported.[conclusion]: the healthcare professional reported that during a thrombectomy procedure, the physician used a neva¿ stent retriever (vesalio) and made two attempts to deliver the device through the 150cm x 20cm dual markers prowler plus microcatheter (6062510x / 30003701), but the device became stuck in the hub of the prowler plus microcatheter.The neva¿ stent retriever was replaced with an embotrap revascularization device (catalog/lot numbers unknown) and the embotrap device was reported to become stuck in the same place; it could not cross the distal part of the microcatheter hub.There was no report of patient injury or complications.Additional information related to the event was requested and was reported to be unavailable.The prowler plus was reported as not available to be returned for evaluation and analysis.Based on complaint information, the device was not available to be returned for analysis.A review of manufacturing documentation associated with this lot (30003701) 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 limited information available and without the product available for analysis, the reported customer complaint 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.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 circumstances of the procedure and/or device manipulation/interaction may have contributed to the reported failure.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.
Event or Problem Description
The healthcare professional reported that during a thrombectomy procedure, the physician used a neva¿ stent retriever (vesalio) and made two attempts to deliver the device through the 150cm x 20cm dual markers prowler plus microcatheter (6062510x / 30003701), but the device became stuck in the hub of the prowler plus microcatheter.The neva¿ stent retriever was replaced with an embotrap revascularization device (catalog/lot numbers unknown) and the embotrap device was reported to become stuck in the same place; it could not cross the distal part of the microcatheter hub.There was no report of patient injury or complications.Additional information related to the event was requested and was reported to be unavailable.The prowler plus was reported as not available to be returned for evaluation and analysis.

• Brand Name: PROWLER PLUS 150/20CM DUAL MRK
• Common Device Name: CATHETER, CONTINOUS FLUSH
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA 02767
• MDR Report Key: 8510509
• Report Number: 1226348-2019-00865
• Device Sequence Number: 1576147
• Product Code: KRA
• UDI-Device Identifier: 10886704028727
• UDI-Public: 10886704028727
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K993266
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/19/2019

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: 11/30/2020
• Device Catalogue Number: 6062510X
• Device Lot Number: 30003701
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/19/2019
• Initial Report FDA Received Date: 04/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1