MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC PRE-SHAPED PROWLER MICROCATHETERS; CATHETER, CONTINOUS FLUSH

Catalog Number	606151JX
Medical Device Problem Code	Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/25/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for analysis; however, the analysis has not yet been completed.Additional information will be submitted within 30 days of receipt.
Event or Problem Description
As reported by a healthcare professional, during a thrombectomy procedure of the middle cerebral artery (m1), a preset lite 3-20 (phenox) became stuck in the prowler 14 microcatheter (606151jx/17448164).It was reported that an internal lumen of.0165¿ is needed for the preset.The prowler was exchanged for an sl-10 microcatheter and the preset could easily be pushed through.An adequate continuous flush had been maintained through the microcatheter.The resistance occurred beyond the hub, but safely in front of the mid catheter.The catheter had not been re-shaped and did not appear damaged.There was no significant delay in the procedure or patient harm reported.It was reported that the preset device will not be returned; however, the prowler was returned for analysis.
Additional Manufacturer Narrative
Conclusion: as reported by a healthcare professional, during a thrombectomy procedure of the middle cerebral artery (m1), a preset lite 3-20 (phenox) became stuck in the prowler 14 microcatheter (606151jx/17448164).It was reported that an internal lumen of.0165¿ is needed for the preset.The prowler was exchanged for an sl-10 microcatheter and the preset could easily be pushed through.An adequate continuous flush had been maintained through the microcatheter.The resistance occurred beyond the hub, but safely in front of the mid catheter.The catheter had not been re-shaped and did not appear damaged.There was no significant delay in the procedure or patient harm reported.A non-sterile preshaped prowler14 j tip 2mrk microcatheter was received coiled inside of a plastic bag.Residues of dry blood were noted on the hub; however, no damages were noted on it.The microcatheter was inspected and no damages were noted on it.The id from the microcatheter were measured and were found within specification.The functional analysis was performed.The prowler 14 received microcatheter was flushed out using a lab sample syringe.The water came out from the distal end of the device.A 0.014¿ guidewire cordis lab sample was introduced into the microcatheter, and it advance smoothly until the microcatheter¿s distal tip without any difficulty.The review of lot 17448164 found one rejected unit (due to tight id) that may be related to the reported complaint; however, inspections are in place that prevents these kinds of damages from leaving the facility.The dhr review confirmed that the rejected unit was properly segregated and discarded.There were no other issues noted that were considered potentially related to the reported complaint.The resistance within the prowler 14 was not confirmed.The device did not present any obvious indication of manufacturing defect or anomaly that could contributed to the event as reported.Neither the product analysis nor the dhr review suggests that the failure could be related to the manufacturing process; therefore no corrective actions will be taken at this time.

• Brand Name: PRE-SHAPED PROWLER MICROCATHETERS
• Common Device Name: CATHETER, CONTINOUS FLUSH
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA
• MDR Report Key: 6390839
• Report Number: 3008264254-2017-00030
• Device Sequence Number: 759702
• Product Code: KRA
• UDI-Device Identifier: 10886704028604
• UDI-Public: (01)10886704028604(17)190228(10)17448164
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K003925
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2017

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: 02/28/2019
• Device Catalogue Number: 606151JX
• Device Lot Number: 17448164
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/14/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/09/2017
• Supplement Report FDA Received Date: 03/28/2017
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PRESET LITE 3-20 (PHENOX)
• Patient Age: 55 YR