MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC PROWLER SEL PLUS 150/5CM 45TIP; CATHETER, CONTINUOUS FLUSH

Catalog Number	606S255FX
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, ethnicity, and medical history were not provided.The name, phone and email address of the initial reporter are not available / reported.[conclusion]: the healthcare professional reported that during the coil embolization of a meningioma at the middle meningeal artery, there was resistance between the 150cm x 5cm prowler select plus microcatheter (606s255fx / 30086380) and the concomitant 0.014-inch guidewire.The microcatheter was replaced with the excelsior® 1018® microcatheter (stryker) and the procedure was completed.There was no report of any patient injury or complication.It was reported that the device will not be returned for investigation due to suspicion of infectious disease.Based on complaint information, the device was not available to be returned for analysis.A review of manufacturing documentation associated with this lot (30086380) 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.The exact cause of the event could not be conclusively determined; 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 the coil embolization of a meningioma at the middle meningeal artery, there was resistance between the 150cm x 5cm prowler select plus microcatheter (606s255fx / 30086380) and the concomitant 0.014-inch guidewire.The microcatheter was replaced with the excelsior® 1018® microcatheter (stryker) and the procedure was completed.There was no report of any patient injury or complication.It was reported that the device will not be returned for investigation due to suspicion of infectious disease.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr is to include the additional event information received on 11/13/2019.[additional information]: the first name, last name, title and phone number of the initial reporter were provided.Updated sections: the initial reporter title, first and last names were added; initial reporter phone: (b)(6).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 SEL PLUS 150/5CM 45TIP
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr.; raynham MA 02767
• MDR Report Key: 9267020
• Report Number: 1226348-2019-01003
• Device Sequence Number: 19401151
• Product Code: KRA
• UDI-Device Identifier: 10886704028857
• UDI-Public: 10886704028857
• 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): 10/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2021
• Device Catalogue Number: 606S255FX
• Device Lot Number: 30086380
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/10/2019
• Supplement Date Received by Manufacturer: 11/13/2019
• Initial Report FDA Received Date: 11/01/2019
• Supplement Report FDA Received Date: 11/13/2019
• 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: 0.014 INCH GUIDEWIRE