MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC PROWLER SELECT MICROCATHETERS; CES MICROCATHETERS (KRA)

Model Number 606S255FX

Device Problem Obstruction of Flow (2423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/03/2014

Event Type  malfunction  

Event Description

During a coil embolization of the patient¿s iia, it was reported that the presidio18 (pc4181550-30/c25650) coil had resistance at 30cm from the middle section of prowler select plus (606-s255fx/16114392) microcatheter (mc).The coil was attempted to be recover, but the coil was stuck.The complaint coil was withdrawn together with the complaint mc, and another mc and a coil were used to continue the procedure, which was successfully completed without further issues.There was no patient injury/complications reported.The complaint products were new and stored per labeling instructions.The procedure was conducted in accordance with the ifu and the constant flush had been maintained at all times.Prior to use, no defect (kink, bends, etc.) was noted on the products by visual inspection.Also no damages were reported on the concomitant devices after the event.There was no stretching or unintended detachment of the coil observed in the vessel or in the microcatheter.It was reported that a radifocus gt gw (terumo, type unknown), a sion blue (asahi intecc, type unknown), a shuttle sheath (cook inc., type unknown), a prowler select plus 45°(lot unknown ¿ different from the complaint product), an unplast (terumo, type unknown), and enpower detachment control box (lot unknown) were also used for the above procedure.No further details of the concomitant devices are available.The vessel was not tortuous and not calcified, and approached was obtained from the right femoral artery.The complaint products will be returned for evaluation.No further information is available.

Manufacturer Narrative

(b)(4).The product was received for evaluation and testing, however, the analysis has not been completed.Additional information will be submitted within 30 days of receipt.This is one of two products used and being reported under complaint (b)(4).

Manufacturer Narrative

During a coil embolization of the patient¿s iia, it was reported that the (b)(4) (pc4181550-30/c25650) coil had resistance at 30cm from the middle section of prowler select plus (606-s255fx/16114392) microcatheter (mc).The coil was attempted to be recover, but the coil was stuck.The complaint coil was withdrawn together with the complaint mc, and another mc and a coil were used to continue the procedure, which was successfully completed without further issues.There was no patient injury/complications reported.The complaint products were new and stored per labeling instructions.The procedure was conducted in accordance with the ifu and the constant flush had been maintained at all times.Prior to use, no defect (kink, bends, etc.) was noted on the products by visual inspection.Also no damages were reported on the concomitant devices after the event.There was no stretching or unintended detachment of the coil observed in the vessel or in the microcatheter.It was reported that a radifocus gt gw (terumo, type unknown), a sion blue (asahi intecc, type unknown), a shuttle sheath (cook inc., type unknown), a prowler select plus 45°(lot unknown ¿ different from the complaint product), an unplast (terumo, type unknown), and enpower detachment control box (lot unknown) were also used for the above procedure.No further details of the concomitant devices are available.The vessel was not tortuous and not calcified, and approached was obtained from the right femoral artery.The complaint products will be returned for evaluation.No further information is available.A non-sterile prowler sel plus 150/5cm 45tip was received coiled inside of a plastic bag.The microcatheter was inspected and it was found bent sections at 7, 26.8, 60.3, 75 and 120.3 cm from the proximal end of hub.No damages were noted on the hub.Some waves were noted on the device; however these appear to occur during the handling of the unit when it was returned for evaluation.The microcatheter was inspected under microscope and was found bent sections.The id of the microcatheter was measured and was found within specification.The functional test was performed according dp 12187777 rev.3.The prowler select plus microcatheter was flushed out using a lab sample syringe (nipro) the water came out from the distal end of the device.Then a 0.018¿ guide wire cordis lab sample was introduced into the microcatheter and it advance smoothly until the microcatheter¿s distal tip and friction was felt when the guidewire was pass through bents section found on the microcatheter.However the guide wire passed totally the microcatheter.The orbit complex lab sample was introduced into the microcatheter and it advance smoothly until the microcatheter¿s distal tip without any difficulty.Friction was found when the orbit complex was passing through bents section found in microcatheter but it passed totally the microcatheter.The failure reported by the costumer as inability to advance the coil/stuck was not confirmed during the functional analysis, since a lab sample coil made through the microcatheter.The damages found during the analysis may have occurred during the shipping process.Neither the analysis nor the dhr suggest that the failure reported could relate to the manufacturing process; additionally inspections are in place that prevents these kinds of damages leaving from the facility.Therefore, no corrective actions will be taken at this time.(b)(4).

Manufacturer Narrative

Product was received for analysis.Additional information will be submitted within 30 days of receipt.(b)(4).

• Brand Name: PROWLER SELECT MICROCATHETERS
• Type of Device: CES MICROCATHETERS (KRA)
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA
• Manufacturer Contact: duane durbin ; 14700 nw 57th court; miami lakes, FL 33014 ; 5088288310
• MDR Report Key: 4205117
• MDR Text Key: 5037718
• Report Number: 1058196-2014-00273
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• PMA/PMN Number: K021591
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/06/2014

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: 03/31/2017
• Device Model Number: 606S255FX
• Device Catalogue Number: 606S255FX
• Device Lot Number: 16114392
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/12/2014
• Initial Date FDA Received: 10/27/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/06/2014; 11/17/2014
• Date Device Manufactured: 04/23/2014
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 68 YR