MAUDE Adverse Event Report: CORDIS DE MEXICO CATH MB 5F PIG 110CM 6SH; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number 532598B

Device Problems Detachment Of Device Component (1104); Inaccurate Dispensing (2955)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/20/2017

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing process that can be related to the reported complaint.  review of lot 17476872 revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint.  the product has been returned for evaluation and testing; however, the engineering evaluation has not been completed.  additional information will be submitted within 30 days of receipt.

Event Description

As reported, after introducing a lunderquist wire over a 5f pig catheter (110cm 6sh), the latter should be removed.But it could not be drawn back into the sluice, as the gold-colored markings on the pigtail partly loosened and pushed together, so that the catheter caught on the sluice.On further pulling, the pigtail tore off at the exit of the sluice in the vessel.After inserting a snare catheter, the pigtail was caught and after a large 14f sluice was pushed over it, it was recovered.The patient has not suffered any injury.  the operation time was extended by about 15 minutes, the applied radiation was considered to be low.  the product will be returned for analysis.There was no difficulty tracking the device through the vasculature.  there was no resistance/friction with another device.  there were no anomalies noted when the device was removed from the package or during prep.  the supply of the aneurysm with the stent graft of the prosthesis main body from the right: after exploration of the left prosthesis leg from transfemoral via an 11f sluice, the advancement of the measuring pigtail catheter was performed over a 0.035 terumo wire followed by an angiography subsequently followed by a length measurement for the contralateral (left) leg.  films are not available.

Manufacturer Narrative

As reported, after introducing a lunderquist wire over a 5f pig catheter (110cm 6sh), the latter should be removed, however it could not be drawn back into the sluice, as the gold-colored markings on the pigtail were partly loosened and pushed together, so that the catheter caught on the sluice.On further pulling, the pigtail tore off at the exit of the sluice in the vessel.After inserting a snare catheter, the pigtail was caught and after a large 14f sluice was pushed over it, it was recovered.The patient has not suffered any injury. the operation time was extended by about 15 minutes.The applied radiation was considered to be low. there was no difficulty tracking the device through the vasculature. there was no resistance/friction with another device. there were no anomalies noted when the device was removed from the package or during prep. after exploration of the left prosthesis leg from transfemoral via an 11f sluice, the advancement of the measuring pigtail catheter was performed over a 0.035 terumo wire followed by an angiography subsequently followed by a length measurement for the contralateral (left) leg. films are not available.  a non-sterile diagnostic cath mb 5f pig 110cm 6sh was received for analysis coiled inside a plastic bag.Per visual analysis, the catheter body was received separated in two parts.The separation was observed at 26 cm from the distal section.Also, during the visual analysis, it was observed that 8 out of 20 marker bands were found moved/out of position at the distal section of the unit.The distal section of the unit was observed under the vision system and the marker band marks on unit¿s surface did not present evidence of damage (scratches, peelings, abrasions, etc.).  however, the unit presented elongation on the catheter body from 13 cm to 23 cm from distal near to the tenth marker band.The catheter showed 8 marker bands (mb 10 and from mb 14 to mb 20) moved from their original place and pile up together.Only marker bands 1 to 9 and marker bands 11 to 13 remained in their original positions.(the position of the marker bands is numerated from the distal end to the hub).No other anomalies/damages were found.The catheter od/id was measured near the separated area and results were found within specification.Also, during the dimensional analysis, the catheter id and od of body shaft was measured between marker bands against drawings and results were found out of tolerance due to the elongated area.Functional analysis could not be performed due to the condition in which the product was received.Catheter was inspected under vision system and elongations were observed on the separation area.Sem analysis was required to determine the root cause of the separation of the catheter body and results showed that the distal and proximal sections of the separated catheter body presented evidence of elongations.The elongations observed suggest that the device was induced to stretching/pulling events that exceed the material yield strength prior to the separation.No other issues were noted during sem analysis.A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing process that can be related to the reported complaint. the complaint reported by the customer as ¿marker band (super torque) - offset/out of position - in-patient ¿and catheter (body/shaft) - separated - in-patient¿ were confirmed due to received product condition.The exact cause of these conditions found could not be conclusively determined during the analysis.However, procedural factors may have contributed to the reported event as evident by elongations which could be attributed to tension forces.According to the product instructions for use, manipulation of the catheter under excessive friction due to interaction with other devices or while trapped in the vasculature, can lead to stretching or elongation of the catheter.Furthermore, if resistance is felt during manipulation, determine the cause of resistance before proceeding and confirm the catheter positioning under high quality fluoroscopic observation.Neither the device history record review nor the product analysis suggests that the event is related to the manufacturing process.Therefore, no corrective or preventative actions will be taken at this time.

• Brand Name: CATH MB 5F PIG 110CM 6SH
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS DE MEXICO; circuito int nte 1820; juarez 32575 ; MX 32575
• Manufacturer (Section G): CORDIS DE MEXICO; circuito int nte 1820; juarez 32575 ; MX 32575
• Manufacturer Contact: cecil navajas ; 14201 nw 60th avenue; miami lakes, FL 33014
• MDR Report Key: 6417605
• MDR Text Key: 70351258
• Report Number: 9616099-2017-00980
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K915836
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/07/2017

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: 03/31/2019
• Device Model Number: 532598B
• Device Catalogue Number: 532598B
• Device Lot Number: 17476872
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2017
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 02/20/2017
• Initial Date Manufacturer Received: 02/20/2017
• Initial Date FDA Received: 03/20/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: LUNDERQUIST WIRE, 14F SLUICE ANS SNARE
• Patient Outcome(s): Required Intervention