MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC PROWLER SELECT LPES J TIP; CATHETER, CONTINUOUS FLUSH

Model Number 606-S155JX

Device Problem Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, weight, race, ethnicity, and medical history were not provided.Date of event: the event occurred in (b)(6) 2020, the exact event date was not reported.The name, phone and email address of the initial reporter are not available / reported.The device is available to be returned for evaluation and testing.However, it has not been received to date as indicated as ¿other¿ in this section as the reason for non-evaluation.If the device returns, a device investigation will be performed.A review of manufacturing documentation associated with this lot (30187163) 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.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 the tip of the 150cm x 5cm, 2 markers, j tip prowler select lpes microcatheter (606s155jx / 30187163) was cracked.There was no report of any patient injury or complication.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr is to report that a re-review of the additional event information received on (b)(6)2020 was performed.The reportability of the file was also reassessed.Based on the information provided, the tip of the 150cm x 5cm, 2 markers, j tip prowler select lpes microcatheter (606s155jx / 30187163) did not become cracked; the tip of the device was kinked.With this information, the file no longer meets the medical device reporting criteria as a malfunction.No further reports will be forthcoming.Updated sections: g.4, g.7, h.2, and h.10.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report the investigational finding of the returned device.[conclusion]: the healthcare professional reported that the tip of the 150cm x 5cm, 2 markers, j tip prowler select lpes microcatheter (606s155jx / 30187163) was cracked.There was no report of any patient injury or complication.Multiple attempts to obtain additional information related to the procedure and the reported device issue were unsuccessful.If additional information is received at a later date, this file will be updated accordingly.The product was returned for evaluation and analysis.The investigational finding is documented below.Investigation summary: the non-sterile prowler select lpes microcatheter was received contained in a pouch.Visual inspection was performed; the body of the device was observed kinked at 52.6 cm from the proximal end.The distal tip of the device was kinked at 0.4 from the distal end.No other damage was noted on the device.Dimensional measurements were taken.The inner diameter (id) and the outer diameter (od) of the prowler select lpes microcatheter were measured and were confirmed to be within specifications.Hub id =.0165¿; specification:.0165¿ minimum.Distal id =.0165¿; specification:.0165¿ minimum.Actual microcatheter od (25cm from distal end) = 0.0296¿; specification: max.0.032¿.The issue documented on the complaint is that the tip of the 150cm x 5cm, 2 markers, j tip prowler select lpes microcatheter was cracked; based on the visual inspection of the returned device, this issue was not confirmed.The microcatheter was observed kinked in the body at 52.6 cm from the proximal end and at 0.4 cm from the distal end, there was another kinked area.The tip of the microcatheter was not cracked as reported.The exact cause of the event could not be conclusively determined; however, the kinked areas observed on the microcatheter appeared to have been caused by excessive force.Based on the device history record review, there is no indication that the event is related to the device manufacturing process.In addition, devices undergo inspection at final assembly to ensure that there are no damages such as the kinked areas observed on the returned microcatheter.Thus, it is unlikely that the 150cm x 5cm, 2 markers, j tip prowler select lpes microcatheter left the manufacturing facility with the kinked areas observed on the body and near the distal tip during the visual inspection performed on the returned device.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.Updated sections: g.4, g.7, h.2, h.3, h.6, 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.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report that the product was received by the product analysis lab on(b)(6) 2020.The return product is pending evaluation.A supplemental 3500a report will be submitted once the product investigation has been completed.Updated sections: d.10, g.4, g.7, h.2, h.3, h.6, 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 SELECT LPES J TIP
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA 02767
• MDR Report Key: 9775775
• MDR Text Key: 198145291
• Report Number: 1226348-2020-00009
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 10886704028789
• UDI-Public: 10886704028789
• 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,Followup,Followup
• Report Date: 02/12/2020

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: 01/31/2022
• Device Model Number: 606-S155JX
• Device Catalogue Number: 606S155JX
• Device Lot Number: 30187163
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2020
• Initial Date Manufacturer Received: 02/12/2020
• Initial Date FDA Received: 03/02/2020
• Supplement Dates Manufacturer Received: 03/25/2020; 03/27/2020; 04/28/2020
• Supplement Dates FDA Received: 03/25/2020; 03/27/2020; 04/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1