MAUDE Adverse Event Report: CORDIS CASHEL SABER RX4MM30CM155; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number 51004030L

Device Problem Structural Problem (2506)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/29/2019

Event Type  malfunction  

Manufacturer Narrative

Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, a plain old balloon angioplasty (poba) was performed with a saber rx pta balloon catheter (4mm30cm155) ), the saber rx pta balloon was inflated within its nominal pressure.However, the balloon got lengthened from about 1.5 to 2-centimeters (cm) from the proximal maker and it was inflated.There was no reported patient injury.Yet, the doctor wondered how long the acceptable length is.The lesion was the superficial femoral artery.Initially, this was a percutaneous transluminal angioplasty (pta) case.A contralateral approach was made with a non-cordis guiding catheter and a non-cordis guide wire crossed the lesion.The contrast to saline ration was 1:1: the device will be returned for analysis.

Manufacturer Narrative

A review of the manufacturing documentation associated with lot (82159348) presented no issues during the manufacturing process that can be related to the reported event.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

A plain old balloon angioplasty (poba) was performed with a saber rx percutaneous transluminal angioplasty (pta) balloon catheter (4mm x 30cm x 155cm), the saber rx pta balloon was inflated within its nominal pressure.However, the balloon got lengthened from about 1.5 to 2-centimeters (cm) from the proximal maker when it was inflated.There was no reported patient injury.Yet, the doctor wondered how long the acceptable length is.The lesion was the superficial femoral artery.Initially, this was a percutaneous transluminal angioplasty (pta) case.A contralateral approach was made with a non-cordis guiding catheter and a non-cordis guide wire crossed the lesion.The contrast to saline ratio was 1:1.The product was returned for analysis.One non-sterile saber rx 4mm x 30cm x 155cm was returned.Per visual analysis, the balloon was coiled inside a plastic bag and seems to have been inflated and deflated.The marker bands were inspected, and no damages or anomalies were observed.A dimensional analysis was performed to verify the correct distance between the distal and proximal marker bands and the distance between the distal/proximal marker bands and balloon shoulders.All measurements were found to be within specification.A product history record (phr) review of lot 82159348 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported "marker band-balloon catheters-offset/out of position - in-patient" was not confirmed during analysis of the returned device.Dimensional analysis revealed the distance between the distal and proximal marker bands, and the distal/proximal marker bands and balloon shoulders were all were found to be within specification.The exact cause of the reported event could not be determined.It is likely procedural factors may have contributed to the reported event.According to the device description in the safety information in the instructions for use ¿the cordis saber percutaneous transluminal angioplasty (pta) dilatation catheter is a catheter with a distal inflatable balloon.Radiopaque marker bands indicate the dilating section of the balloon and aid in balloon placement.For balloon lengths greater than or equal to 100mm, the distal section will have one (1) marker band and proximal section will consist of two (2) adjacent marker bands.For balloon lengths less than 100mm, the distal and proximal section will have each one (1) marker band.The catheter tip is tapered to ease entry into peripheral arteries and to facilitate the crossing of tight stenoses.The radiopaque marker bands (the length between the outer edge of most proximal to the outer edge of most distal marker band) indicate the stated nominal length of the balloon.¿ the product analysis suggests that the event experienced by the customer could be related to the manufacturing process; therefore, a corrective/preventive action will be taken at this time.

Manufacturer Narrative

After further review of additional information received the following sections h10 (complaint conclusion) have been updated accordingly.A plain old balloon angioplasty (poba) was performed with a saber rx percutaneous transluminal angioplasty (pta) balloon catheter (4mm x 30cm x 155cm), the saber rx pta balloon was inflated within its nominal pressure.However, the balloon got lengthened from about 1.5 to 2-centimeters (cm) from the proximal maker when it was inflated.There was no reported patient injury.Yet, the doctor wondered how long the acceptable length is.The lesion was the superficial femoral artery.Initially, this was a percutaneous transluminal angioplasty (pta) case.A contralateral approach was made with a non-cordis guiding catheter and a non-cordis guide wire crossed the lesion.The contrast to saline ratio was 1:1.The product was returned for analysis.One non-sterile saber rx 4mm x 30cm x 155cm was returned.Per visual analysis, the balloon was coiled inside a plastic bag and seems to have been inflated and deflated.The marker bands were inspected, and no damages or anomalies were observed.A dimensional analysis was performed to verify the correct distance between the distal and proximal marker bands and the distance between the distal/proximal marker bands and balloon shoulders.All measurements were found to be within specification.A product history record (phr) review of lot 82159348 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported "marker band-balloon catheters-offset/out of position - in-patient" was not confirmed during analysis of the returned device.Dimensional analysis revealed the distance between the distal and proximal marker bands, and the distal/proximal marker bands and balloon shoulders were all were found to be within specification.However, it was determined that although the device was within specification, variation within the specification allowed some differences in location of the markers in relation to the balloon shoulders.According to the device description in the safety information in the instructions for use ¿the cordis saber percutaneous transluminal angioplasty (pta) dilatation catheter is a catheter with a distal inflatable balloon.Radiopaque marker bands indicate the dilating section of the balloon and aid in balloon placement.For balloon lengths greater than or equal to 100mm, the distal section will have one (1) marker band and proximal section will consist of two (2) adjacent marker bands.For balloon lengths less than 100mm, the distal and proximal section will have each one (1) marker band.The catheter tip is tapered to ease entry into peripheral arteries and to facilitate the crossing of tight stenoses.The radiopaque marker bands (the length between the outer edge of most proximal to the outer edge of most distal marker band) indicate the stated nominal length of the balloon.¿ the product analysis suggests that the event experienced by the customer could be related to the manufacturing process; therefore, a corrective/preventive action will be taken at this time.

• Brand Name: SABER RX4MM30CM155
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co.; tipperary ; EI
• MDR Report Key: 8743846
• MDR Text Key: 150280119
• Report Number: 9616099-2019-03042
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2021
• Device Catalogue Number: 51004030L
• Device Lot Number: 82159348
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: - CONTRAST MEDIA (OYPALOMIN 370 FUJIPHARMA); - GUIDE WIRE (CRUISE, ASAHI INTECC); - GUIDING CATHETER (DESTINATION TERUMO); - INFLATION DEVICE (GM-30F NIPRO)