MAUDE Adverse Event Report: PROWLER-14 DUAL MARKER; CATHETER, CONTINOUS FLUSH

Model Number	606-151X
Medical Device Problem Code	Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).The device has not been returned.If the device returns, a device investigation will be performed.Additional information will be submitted within 30 days of receipt.Product complaint # (b)(4).
Event or Problem Description
The healthcare professional reported that during the coil embolization procedure of an aneurysm on the internal carotid artery, the physician deployed the orbit galaxy g2 3x4 coil through the prowler-14 dual maker microcatheter (606151x / 17488447) in attempt to coil the aneurysm, but the coil encountered resistance.The physician exchanged the to another prowler-14 microcatheter and successfully deployed the coil.A total of 8 coils were deployed after the first coil.There was no report of patient injury or complication associated with the reported event.
Additional Manufacturer Narrative
(b)(4).[conclusion]: the healthcare professional reported that during the coil embolization procedure of an aneurysm on the internal carotid artery, the physician deployed the orbit galaxy g2 3x4 coil through the prowler-14 dual marker microcatheter (606151x / 17488447) in attempt to coil the aneurysm, but the coil encountered resistance.There were no visible kinks or damages observed on the microcatheter.It was confirmed that the microcatheter was not obstructed, adequate and continuous flush was maintained through the microcatheter; the guidewire did not experience any resistance when it was advanced through the microcatheter.The physician exchanged the to another prowler-14 microcatheter and successfully deployed the coil.A total of 8 coils were deployed after the first coil.There was no report of patient injury or complication associated with the reported event.A non-sterile prowler-14 dual marker was received coiled inside of a pouch.The device was inspected and it was found compressed at 2cm and 35cm from the distal end.Residues of dry blood can be observed along of the body of the received device.The micro-catheter was inspected under microscope and it was found compressed.The inner diameter (id) and outer diameter (od) of the microcatheter were measured and were found to be within specifications.The functional test cannot be performed due to the received microcatheter was received saturated with dry blood.An x-ray was performed on the body of the received device and was noted that part of an unknown device was observed inside of the microcatheter.The reported issue was confirmed with the x-ray taken of the body of the device.The reported event by the customer is most likely due to the compressed sections at 2cm and 35cm from the distal end.The observed unknown device under x-ray was also a likely cause of the reported issue.The compressed sections observed on the body of the received microcatheter was most likely caused by applied excessive force on the device.The root cause of the event could not be conclusively determined; however, procedural / handling factors may have contributed to the event.A review of the manufacturing documentation associated with this lot 17488447 presented no issues during the manufacturing or inspection process that can be related to the reported complaint.In addition, there are inspections in place to prevent this kind of failure from leaving the facility.As part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective/preventive action may be triggered at a later time.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no corrective actions will be taken at this time.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.
Additional Manufacturer Narrative
(b)(4).The healthcare professional reported that during the coil embolization procedure of an aneurysm on the internal carotid artery, the physician deployed the orbit galaxy g2 3x4 coil through the prowler-14 dual marker microcatheter (606151x /17488447) in attempt to coil the aneurysm, but the coil encountered resistance.The physician exchanged the to another prowler-14 microcatheter and successfully deployed the coil.A total of 8 coils were deployed after the first coil.There was no report of patient injury or complication associated with the reported event.A non-sterile prowler-14 dual marker was received coiled inside of a pouch.The device was inspected and it was found compressed at 2cm and 35cm from the distal end.Residues of dry blood can be observed along of the body of the received device.The micro-catheter was inspected under microscope and it was found compressed.The inner diameter (id) and outer diameter (od) of the microcatheter were measured and were found to be within specifications.The functional test cannot be performed due to the received microcatheter was received saturated with dry blood.An x-ray was performed on the body of the received device and was noted that part of an unknown device was observed inside of the microcatheter.The reported issue was confirmed with the x-ray taken of the body of the device.The reported event by the customer is most likely due to the compressed sections at 2cm and 35cm from the distal end.The observed unknown device under x-ray was also a likely cause of the reported issue.The compressed sections observed on the body of the received microcatheter was most likely caused by applied excessive force on the device.The root cause of the event could not be conclusively determined; however, procedural/handling factors may have contributed to the event.A review of the manufacturing documentation associated with this lot 17488447 presented no issues during the manufacturing or inspection process that can be related to the reported complaint.In addition, there are inspections in place to prevent this kind of failure from leaving the facility.Additional information will be submitted within 30 days of receipt.

• Brand Name: PROWLER-14 DUAL MARKER
• Common Device Name: CATHETER, CONTINOUS FLUSH
• MDR Report Key: 7297766
• Report Number: 3008264254-2018-00509
• Device Sequence Number: 16485881
• Product Code: KRA
• UDI-Device Identifier: 10886704028628
• UDI-Public: (01)10886704028628(11)160518(17)190430(10)17488447
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K972518
• 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,Followup
• Report Date (Section B): 02/04/2018

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: 04/30/2019
• Device Model Number: 606-151X
• Device Catalogue Number: 606151X
• Device Lot Number: 17488447
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2018
• Initial Date Received by Manufacturer: 02/04/2018
• Supplement Date Received by Manufacturer: 02/04/2018; 02/04/2018
• Initial Report FDA Received Date: 02/26/2018
• Supplement Report FDA Received Date: 04/13/2018; 05/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1