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

Catalog Number 606S255X

Device Problem Obstruction of Flow (2423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/16/2015

Event Type  malfunction  

Event Description

(ref: (b)(4)) resistance / stuck.The physician attempted to place the complaint vrd (enc452200 / 10434680) from the lt-pca to the ba.However, when the physician began inserting the vrd into the complaint prowler select plus (606-s255x / 17077997), he experienced a severe resistance around the mc hub.The physician attempted to withdrew the vrd back into the introducer, but the vrd got deployed in the mc hub.The prowler was withdrawn from the patient.The physician inserted the gw into the mc to check the bore, and experienced a severe friction abound the hub.It was suspected that the bore of the mc was somehow damaged.Thus, it was replaced with another prowler (different lot #) to continue the procedure.The procedure was then completed without further issues, but due to the event the procedure was delayed for 30 minutes.Nevertheless, the delay was not clinically significant as there were no patient injury/complications.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.The introducer had been seated properly into the mc hub before starting the insertion.No visible damage was noted on the product prior to the event.Due to the fact that the patient was a hcv carrier, the complained products have already been disposed.No further information is available.The procedure was the vrd-assisted coil embolization of an aneurysm at the ba-top to treat the sah.The patient was a (b)(6) female, whose vessels were neither torturous nor calcified.A chikai (asahi intecc, 0.014¿), a fubuki (asahi intecc, 5fr), and an okay ii (goodman) were used for this procedure.

Manufacturer Narrative

The product will be return for analysis, but it has not been received.Additional information will be submitted within 30 days of receipt.(b)(4).Additional products used with the device.Chikai 0.014¿ gw, 5fr fubuki catheter, and an okay ii (goodman).This is one of two products for complaint (b)(4).

Manufacturer Narrative

This report is being submitted because we became aware that follow up 1 was accidentally reported as follow up 2.Therefore, are resubmitting this information to correct the sequencing.The physician attempted to place the complaint vrd (enc452200 / 10434680) from the lt-pca to the ba.However, when the physician began inserting the vrd into the complaint prowler select plus (606-s255x / 17077997), he experienced a severe resistance around the mc hub.The physician attempted to withdrew the vrd back into the introducer, but the vrd got deployed in the mc hub.The prowler was withdrawn from the patient.The physician inserted the gw into the mc to check the bore, and experienced a severe friction abound the hub.It was suspected that the bore of the mc was somehow damaged.Thus, it was replaced with another prowler (different lot #) to continue the procedure.The procedure was then completed without further issues, but due to the event the procedure was delayed for 30 minutes.Nevertheless, the delay was not clinically significant as there were no patient injury/complications.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.The introducer had been seated properly into the mc hub before starting the insertion.No visible damage was noted on the product prior to the event.Due to the fact that the patient was a hcv carrier, the complained products have already been disposed.No further information is available.The procedure was the vrd-assisted coil embolization of an aneurysm at the ba-top to treat the sah.The patient was a 71 year-old female, whose vessels were neither torturous nor calcified.A chikai (asahi intecc, 0.014¿), a fubuki (asahi intecc, 5fr), and an okay ii (goodman) were used for this procedure.The device was not returned for analysis, but device history records associated with this lot presented no issues during the manufacturing or inspection process that can be related to the reported complaint.Without the device, the reported event was not confirmed, but based on the information the event could be related to procedural factors.Procedural factors may have impacted the event.Additionally, the history records indicate this product was final inspection tested at (b)(6) and was determined to be acceptable.Therefore, no corrective actions will be taken at this time.When this medwatch was originally submitted in 2012, imdrf codes were not used, and the now obsolete fda codes were used.Therefore, the below code was applicable during time of original submission: result code: 3221.

Manufacturer Narrative

The physician attempted to place the complaint vrd (enc452200 / 10434680) from the lt-pca to the ba.However, when the physician began inserting the vrd into the complaint prowler select plus (606-s255x / 17077997), he experienced a severe resistance around the mc hub.The physician attempted to withdrew the vrd back into the introducer, but the vrd got deployed in the mc hub.The prowler was withdrawn from the patient.The physician inserted the gw into the mc to check the bore, and experienced a severe friction abound the hub.It was suspected that the bore of the mc was somehow damaged.Thus, it was replaced with another prowler (different lot #) to continue the procedure.The procedure was then completed without further issues, but due to the event the procedure was delayed for 30 minutes.Nevertheless, the delay was not clinically significant as there were no patient injury/complications.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.The introducer had been seated properly into the mc hub before starting the insertion.No visible damage was noted on the product prior to the event.Due to the fact that the patient was a hcv carrier, the complained products have already been disposed.No further information is available.The procedure was the vrd-assisted coil embolization of an aneurysm at the ba-top to treat the sah.The patient was a 71 year-old female, whose vessels were neither torturous nor calcified.A chikai (asahi intecc, 0.014¿), a fubuki (asahi intecc, 5fr), and an okay ii (goodman) were used for this procedure.The device was not returned for analysis, but device history records associated with this lot presented no issues during the manufacturing or inspection process that can be related to the reported complaint.Without the device, the reported event was not confirmed, but based on the information the event could be related to procedural factors.Procedural factors may have impacted the event.Additionally, the history records indicate this product was final inspection tested at lake region medical and was determined to be acceptable.Therefore, no corrective actions will be taken at this time.

• 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: 4759410
• MDR Text Key: 15223011
• Report Number: 1058196-2015-00095
• 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,Consumer,Health Professional,User Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2017
• Device Catalogue Number: 606S255X
• Device Lot Number: 17077997
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/17/2015
• Date Device Manufactured: 08/12/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Sex: Female