MAUDE Adverse Event Report: CORDIS NEUROVASCULAR, 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 04/18/2014

Event Type  malfunction  

Event Description

During coil embolization of the hepatic artery, the coil size of the presidio (pc4181034-30/c13105) was not proper for the target lesion, so the physician wanted to re-sheath it.However, while withdrawing the presidio from the patient, there was severe resistance into the prowler select plus (606-s255x/15886422).Shortly after, the coil unintentionally detached around the middle section of the microcatheter although no detachment was attempted at that time.Therefore both the entire presidio and the prowler select plus were safely removed as a unit from the patient.The procedure was continued using a new coil (pc4181034-30, lot unknown).It is unknown if the microcatheter was replaced or not.Afterwards, the procedure was successfully completed without any further issues.There was no patient injury/complications reported.The complaint products were new and were 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.It is unknown if the microcatheter was re-shaped or not.The complaint products are going to be returned for evaluation.No additional information is available.The preliminary analysis revealed the coil was not detached, but that the coil was encased in blood inside the microcatheter.An rotatin hemostasis valve (rhv) was not attached to the device.When the microcatheter was opened to analyze the coil, the coil was found to be stretched.The microcatheter has been sent for further analysis.

Manufacturer Narrative

(b)(4).Additional information will be submitted within 30 days of receipt.This is 1 of 2 mdrs associated with this complaint with associated manufacturer report numbers of 1226348-2014-00108 and 1058196-2014-00163.

Manufacturer Narrative

No additional information could be obtained to explain why the microcatheter was full of blood and no rhv was attached to the device.Complaint conclusion: during coil embolization of the hepatic artery, the coil size of the presidio (pc4181034-30/(b)(4), complaint product) was not proper for the target lesion, so the physician wanted to re-sheath it.It was reported that there was severe resistance while withdrawing the presidio from the prowler select plus (606-s255x/15886422), and the coil unintentionally detached around the middle section of the microcatheter; however, product analysis revealed that the coil was stretched and was not detached.Both the entire presidio and the prowler select plus were safely removed as a unit from the patient.The procedure was continued using a new coil (pc4181034-30, lot unknown) and microcatheter.Afterwards, the procedure was successfully completed without any further issues.There was no patient injury/complications reported.The complaint products were new and were stored per labeling instructions.It was reported that 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.It is unknown if the microcatheter was re-shaped or not.No additional information was available.A non-sterile select plus 150/5 cm was received in several pieces (ten) inside of a plastic bag.The device was inspected and it was found compressed as well as separate (cut) sections were noted on it.Residues of dry blood can be observed on the hub.The microcatheter was inspected under microscope and the damages found o the visual analysis was confirmed [compressed/separated (cut) sections].The od and id from the microcatheter were measured and were found within specification.The functional test could not be performed due to the microcatheter was received in several pieces (ten).Note: during analysis of the coil, the catheter was severely damaged in order to remove the coil from the microcatheter.Prior to this destruction, it was noted that the distal section of the microcatheter had several severely compressed sections.The review of lot 15886422 revealed no issues that were considered potentially related to the reported complaint.The reported premature detachment was not confirmed since the coil was found to be attached during product analysis.Coil stretching was confirmed during analysis.Resistance/friction was confirmed, as the coil was returned encased in blood within the microcatheter.Although the root cause of the stretching and resistance/friction could not be conclusively determined, procedural/handling factors that are addressed in the ifu may have contributed to the complaint.Although it was reported that a continuous flush had been maintained within the microcatheter, the returned coil was returned with blood inside the inner lumen and the rhv was not attached to the device.In order to maintain a flush and prevent blood from entering the microcatheter, a rhv must be attached.There were no issues found during product analysis that could be related to a manufacturing issue, therefore, no corrective actions will be taken.This is 1 of 2 mdrs associated with this complaint with associated manufacturer report numbers of 1226348-2014-00108 and 1058196-2014-00163.

• Brand Name: PROWLER SELECT MICROCATHETERS
• Type of Device: CES MICROCATHETERS (KRA)
• Manufacturer (Section D): CORDIS NEUROVASCULAR, INC.; 14700 nw 57th court; miami lakes FL 33014
• Manufacturer (Section G): CODMAN AND SHURTLEFF, INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: duane durbin ; miami lakes, FL 33014
• MDR Report Key: 3846903
• MDR Text Key: 4409077
• Report Number: 1058196-2014-00163
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K021591
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/21/2014

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: 04/30/2016
• Device Catalogue Number: 606S255X
• Device Lot Number: 15886422
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/03/2014
• Initial Date FDA Received: 06/04/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/11/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1