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 07/15/2015

Event Type  malfunction  

Event Description

It was reported that, when inserting the enterprise vrd ((b)(4)/lot unk) into the prowler select plus 150/5cm (psp/606-s255x / 17198164)., the physician experienced a severe resistance at the va.He stopped inserting and withdrew the complaint vrd with psp.Instead, an enterprise2 23cm (lot unknown) with another prowler were successfully placed at the target lesion site.It was also reported that, when inserting the prowler into the cerulean, the delivery was not very smooth although it was completely inserted.The physician could not specify which instrument had caused the resistance.The replaced e2 was shorter than the complained one, thus it could be no resistance when inserting.The procedure was completed without further issues.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.No visible damage was noted on the products prior to the event.There was no unintended detachment of the vrd observed in the mc.The complained enterprise will be returned for analysis, but the prowler was discarded.After the event, no damages noticed on the device (kink, bend, stretched, fracture, separate, etc.), and the vrd was still attached when the enterprise was withdrawn from the patient.However, the vrd was detached after the procedure.Nevertheless, the vrd will be returned as well.No further information is available.The procedure was the vrd-assisted coil embolization of an aneurysm at the ba-tip, approached from the rt-fa.The patient¿s sex and dob was unknown, whose vessels were consecutively and heavily torturous at va but the calcification level was not available.A guiding catheter by medikit (4f cerulean), a micro catheter by prowler select plus (lot unknown), a y-connecter (model unknown), and a dcb by enpower (lot unknown) were used for this procedure.

Manufacturer Narrative

(b)(4).The product will not be returned for analysis, and additional information will be submitted within 30 days of receipt.

Manufacturer Narrative

A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection process that can be related to the reported complaint.The product was received for analysis.

Manufacturer Narrative

It was reported that, when inserting the enterprise vrd (enc403000/lot unk) into the prowler select plus 150/5cm (psp/606-s255x / 17198164).The physician experienced a severe resistance at the va.He stopped inserting and withdrew the complaint vrd with psp.Instead, an enterprise2 23cm (lot unknown) with another prowler were successfully placed at the target lesion site.It was also reported that, when inserting the prowler into the cerulean, the delivery was not very smooth although it was completely inserted.The physician could not specify which instrument had caused the resistance.The replaced e2 was shorter than the complained one, thus it could be no resistance when inserting.The procedure was completed without further issues.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.No visible damage was noted on the products prior to the event.There was no unintended detachment of the vrd observed in the mc.The complained enterprise will be returned for analysis, but the prowler was discarded.After the event, no damages noticed on the device (kink, bend, stretched, fracture, separate, etc.), and the vrd was still attached when the enterprise was withdrawn from the patient.However, the vrd was detached after the procedure.Nevertheless, the vrd will be returned as well.No further information is available.The procedure was the vrd-assisted coil embolization of an aneurysm at the ba-tip, approached from the rt-fa.The patient¿s sex and dob was unknown, whose vessels were consecutively and heavily torturous at va but the calcification level was not available.A guiding catheter by medikit (4f cerulean), a micro catheter by prowler select plus (lot unknown), a y-connecter (model unknown), and a dcb by enpower (lot unknown) were used for this procedure.The prowler microcatheter was not available for analysis, and the dhr indicated that the manufacturing documentation 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 could not be confirmed, however based on the information, it appears that procedural factors may have contributed to the event.Additionally, the dhr indicated that the manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection process that can be related to the reported complaint.Therefore, no corrective actions will be taken at this time.This is one of two products associated with mdr # 1226348-2015-00004.

• 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: kimberly soter ; 14700 nw 57th court; miami lakes, FL 33014 ; 5089777396
• MDR Report Key: 4947256
• MDR Text Key: 6033212
• Report Number: 1058196-2015-00155
• 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,Company Representative,company represent
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 08/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2018
• Device Catalogue Number: 606S255X
• Device Lot Number: 17198164
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/12/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1