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

Model Number 606-S255FX

Device Problem Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/10/2019

Event Type  malfunction  

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 procedure, the 150cm x 5cm prowler select plus microcatheter (606s255fx / 30248169) was advanced toward the m1 segment to implant a 4.0mm x 16mm enterprise® 2 vascular reconstruction device (enc401600 / 11004256), the enterprise stent was inserted in the microcatheter but strong resistance was felt before the enterprise stent exited the microcatheter; the stent was not able to advance.The prowler select plus microcatheter was replaced with another 150cm x 5cm prowler select plus microcatheter from a different lot (30239459); with this replacement microcatheter, the enterprise stent also experienced strong resistance, but the physician was able to deliver, deploy and implant the enterprise stent at the intended location.There was no report of any patient adverse event or complication as a result of the reported issue.Based on complaint information, the device was not available to be returned for analysis.A review of manufacturing documentation associated with this lot (30248169) 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.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.It is possible that circumstances of the procedure and / or device manipulation / interaction may have contributed to the reported device issue.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.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 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 Description

The healthcare professional reported that during the procedure, the 150cm x 5cm prowler select plus microcatheter (606s255fx / 30248169) was advanced toward the m1 segment to implant a 4.0mm x 16mm enterprise® 2 vascular reconstruction device (enc401600 / 11004256), the enterprise stent was inserted in the microcatheter but strong resistance was felt before the enterprise stent exited the microcatheter; the stent was not able to advance.The prowler select plus microcatheter was replaced with another 150cm x 5cm prowler select plus microcatheter from a different lot (30239459); with this replacement microcatheter, the enterprise stent also experienced strong resistance, but the physician was able to deliver, deploy and implant the enterprise stent at the intended location.There was no report of any patient adverse event or complication as a result of the reported issue.

Manufacturer Narrative

Manufacturer¿s ref.No: pc-(b)(4).The purpose of this mdr is to include the additional event information received on (b)(6)2020.[additional event information]: it was confirmed that the reported event did not result in any clinicially significant procedural delay.E.1: the initial reporter phone: (b)(6).Updated sections: e.1, e.3, g.4, g.7, h.2, and h.10.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
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA 02767
• MDR Report Key: 9511837
• MDR Text Key: 203848721
• Report Number: 1226348-2019-01032
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 10886704028857
• UDI-Public: 10886704028857
• Combination Product (y/n): N
• PMA/PMN Number: K021591
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/10/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: 606-S255FX
• Device Catalogue Number: 606S255FX
• Device Lot Number: 30248169
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/10/2019
• Initial Date FDA Received: 12/23/2019
• Supplement Dates Manufacturer Received: 01/21/2020
• Supplement Dates FDA Received: 01/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ENTERPRISE2 4MMX16MM NO TIP